List of Microbial Tests
Microorganism | Trade Name | Manufacturer | Submission |
---|---|---|---|
Adenovirus | Adenovirus R-gene US | Argene SA | K121942 |
Lyra Adenovirus Assay | Quidel Corportation | K141931 | |
ProAdeno+ Assay | Gen-Probe Prodesse, Inc. | K102952 | |
Prodesse ProAdeno + Assay | Gen-Probe Prodesse, Inc. | K132159 | |
Antimicrobial resistance | GenePOC Carba | GenePOC Inc. | K190275 |
Bacillus Anthracis | JBAIDS Anthrax Detection System | Idaho Technology, Inc. | K131930, K071188, K051713 |
Bacillus Anthracis | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | K192871 |
Bacterial vaginosis (BV) markers | Aptima BV Assay | Hologic, Inc. | K190452 |
Bordetella | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | K163626, K163626/S001 |
AMPLIVUE BORDETELLA ASSAY | QUIDEL CORPORATION | K143206 | |
Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | K170284 | |
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMA | MERIDIAN BIOSCIENCE, INC. | K133673, K152285 | |
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK | DIASORIN MOLECULAR LLC | K173498 | |
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK | DIASORIN MOLECULAR LLC | K183223 | |
Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei | Affirm VPIII Microbial Identification Test | Microprobe Corp. | K931151, K931374 |
Yeast Traffic Light PNA FISH | AdvanDx, Inc. | K093024, K080719 | |
C. albicans / C. glabrata PNA FISH | AdvanDx, Inc. | K092784 | |
C. albicans PNA FISH | AdvanDx, Inc. | K092655, K062461 | |
C. Albicans screen | Carr-Scarborough Microbiologicals, Inc. | K891476 | |
T2Candida 1.1 Panel | T2 Biosystems, Inc. | K173536 | |
Candida glabrata / Candida species group / Trichomonas vaginalis (TV) | Aptima CV/TV Assay | Candida glabrata / Candida species group / Trichomonas vaginalis (TV) | K190472 |
Clostridium difficile | ARIES C. difficile Complete Kit, ARIES C. difficile Assay Protocol File Kit | Luminex | K171441 |
Solana C. difficile Assay | Quidel Corporation | K170491 | |
ICEPlex C. difficile Kit | PrimeraDx | K132726 | |
IMDx C. difficile for Abbott m2000 | Intelligent Medical Devices, Inc. | K132235 | |
BD Diagnostics BD MAX Cdiff Assay | GeneOhm Sciences Canada Inc. | K130470 | |
Quidel Molecular Direct C. difficile Assay | Quidel Corporation | K123998 | |
Verigene C. Difficile Nucleic acid Test | Nanosphere, Inc. | K123197 | |
Portrait Toxigenic C. difficile Assay | Great Basin Scientific, Inc. | K113358 | |
Simplexa C. difficile Universal Direct Assay | Focus Diagnostics, Inc. | K113433, K163085, K163085/S001 | |
Xpert C. difficile/Epi | Cepheid | K110203 | |
Illumigene C. difficile DNA Amplification Assay | Meridian Bioscience, Inc. | K110012 | |
Illumigene C. difficile Assay | Meridian Bioscience, Inc. | K100818, K110012 | |
Xpert C. difficile | Cepheid | K091109 | |
ProGastro Cd Assay | Prodesse Inc. | K090239 | |
BD GeneOhm C. diff Assay | BD Diagnostics/ GeneOhm Sciences, Inc. | K081920 | |
ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN, GMBH | K133936 | |
AMPLIVUE C. DIFFICILE ASSAY | QUIDEL CORPORATION | K123355 | |
GenePOC CDiff | GenePOC Inc | K172569 | |
Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System | Roche Molecular Systems, Inc. | K171770 | |
Clostridium difficile QC material | Cepheid Xpert C. Difficile/Epi Control Panel | Microbiologics, Inc. | K190463 |
Coxiella burnetii | Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit | Idaho Technology, Inc. | K103207 |
Chlamydia trachomatis / Neisseria gonorrhoeae | Abbott RealTime CT/NG and Multi-Collect Specimen Collection Kit | Abbott Molecular Inc. | K092704, K080739 |
Accuprobe Neisseria gonorrhoeae Culture Confirmation Test | Gen-Probe, Inc. | K895583 | |
Amplicor Chlamydia trachomatis Test | Roche Molecular Systems, Inc. | K922906 | |
AMPLICOR CT/NG Test for Chlamydia trachomatis | Roche Molecular Systems, Inc. | K973707 | |
AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Diagnostics Corp. | K070174 | |
AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Diagnostics Corp. | K070172 | |
APTIMA Combo 2 Assay | Gen-Probe, Inc. | K111409 | |
APTIMA Combo 2 Assay (Panther System) | Hologic/Gen-Probe, Inc. | K132251 | |
BD MAX CT/GC/TV, BD MAX Instrument | Becton, Dickinson, & Co. | K151589, K151589/S001, K151589/S002 | |
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091724, K090824, K081824 | |
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091730, K090971, K090827, K081825 | |
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT System | Becton, Dickinson, & Co. | K140446 | |
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System | Becton, Dickinson, & Co. | K140048 | |
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | Becton Dickinson Microbiology Systems | K984631 | |
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | Becton, Dickinson, & Co. | K012351 | |
binx health io CT/NG Assay | binx health, Inc. | K191352 | |
COBAS 4800 CT/NG Test | Roche Molecular Systems, Inc. | K110923 | |
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Molecular Systems, Inc. | K973718 | |
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Diagnostics Corp. | K053287 | |
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K974342 | |
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Diagnostics Corp. | K053289 | |
COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMS | Roche Molecular Systems, Inc. | K173887 | |
cobas CT/NG v2.0 Test | Roche Molecular Systems, Inc. | K132270, K140887, K163184 | |
GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay Kit | Gen-Probe, Inc. | K962217 | |
GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae | Gen-Probe, Inc. | K063664, K062440, K043144 | |
GEN-PROBE APTIMA Assay for Chlamydia trachomatis | Gen-Probe, Inc. | K063451, K053446, K043072 | |
GEN-PROBE APTIMA Combo 2 Assay | Gen-Probe, Inc. | K043224, K032554, K003395 | |
GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeae | Gen-Probe, Inc. | K940979 | |
GONOSPOT DNA Probe Culture Confirmation Test | Ortho Diagnostic Systems, Inc. | K872628 | |
GONOSTAT Gonococcal Detection Kit | Sierra Diagnostics, Inc. | K991268 | |
Hybrid Capture II CT/GC Test | Digene Corp. | K981567, K010891 | |
Hybrid Capture II CT-ID Test | Digene Corp. | K990023, K010892 | |
Hybrid Capture II GC-ID Test | Digene Corp. | K981485, K010893 | |
LCx Chlamydia trachomatis Assay | Abbott Laboratories | K934622 | |
LCx Neisseria gonorrhoeae Assay | Abbott Laboratories | K935833 | |
PACE 2 Chlamydia trachomatis probe confirmation assay | Gen-Probe, Inc. | K920302 | |
PACE 2 Neisseria gonorrhoeae probe confirmation assay | Gen-Probe, Inc. | K920301 | |
PACE 2 System for Chlamydia trachomatis | Gen-Probe, Inc. | K920378 | |
GEN-PROBE PACE System for Chlamydia trachomatis | Gen-Probe, Inc. | K874878 | |
GEN-PROBE System for Neisseria gonorrhoeae | Gen-Probe, Inc. | K874620 | |
PACE System for Neisseria gonorrhoeae | Gen-Probe, Inc. | K881277 | |
Rapid Diagnostic System for Chlamydia trachomatis | Gen-Probe, Inc. | K871878 | |
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K974503 | |
Roche COBAS AMPLICOR Chlamydia trachomatis test | Roche Molecular Systems, Inc. | K964507 | |
TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatis | Gen-Probe, Inc. | K061413 | |
TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae | Gen-Probe, Inc. | K061509 | |
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 Assay | Gen-Probe, Inc. | K060652 | |
Xpert CT/NG | Cepheid | K121710 | |
Xpert CT/NG | Cepheid | K190441 | |
Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | K190515 | |
Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV) | BD MAX CTGCTV2 (assay); BD MAX (instrument) | Becton, Dickinson & Co. (BD) | K182692 |
CT/GC/TV QC material | BD MAX CT/GC/TV 20-DAY QC PANEL | MICROBIOLOGICS, INC. | K181683 |
CT/GC QC material | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | K190223 |
Cytomegalovirus | Abbott RealTime CMV | Abbott Molecular | P160044 |
ARTUS CMV RGQ MDX Kit | QIAGEN | P130027 S001-S002 | |
COBAS CMV Test | Roche Molecular Systems | P160041 S001 | |
COBAS AmpliPrep/COBAS TaqMan CMV Test | Roche Molecular Systems | P110037 S001-S031 | |
NucliSens CMV pp67 | Organon Teknika Corporation | K983762 | |
Dengue virus | CDC DENV-1-4 Real-Time RT-PCR Assay | Centers for Disease Control and Prevention | K113336 |
Entercoccus | IMDx Van R for Abbott m2000 | Intelligent Medical Devices, Inc. | K123753 |
BD GeneOhm VanR Assay | BD Diagnostics (GeneOhm Sciences, Inc.) | K102416 | |
Xpert vanA Assay | Cepheid | K092953 | |
E. faecalis/OE PNA | AdvanDx, Inc. | K083074 | |
GBS PNA FISH | AdvanDx, Inc. | K082612 | |
E. faecalis PNA FISH culture identification kit | AdvanDx, Inc. | K063127 | |
Enteric parasite QC material | BD MAX ENTERIC PARASITE CONTROL PANEL, BD MAX ENTERIC PARASITE 20-DAY QC PANEL | MICROBIOLOGICS, INC. | K181711 |
Enterovirus | NucliSens EasyQ Enterovirus vl.1 Assay | bioMĂ©rieux, Inc. | K093383, K063261 |
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa | GNR Traffic Light PNA FISH | AdvanDx, Inc. | K101558 |
E. coli/P. aeruginosa PNA FISH | AdvanDx, Inc. | K092236, K081309 | |
EK/P aeruginosa PNA FISH | AdvanDx, Inc. | K092393, K081433 | |
E. coli PNA FISH | AdvanDx, Inc. | K082068 | |
Francisella tularensis | JBAIDS Tularemia Detection Kit | Idaho Technology, Inc. | K072547 |
Fungal Pathogen Panel | EPLEX BLOOD CULTURE IDENTIFICATION PANEL FUNGAL PATHOGEN (BCID-FP) PANEL | GENMARK DIAGNOSTICS, INCORPORATED | K182690 |
Gram-Positive / Gram-Negative Bacteria | Accelerate Pheno System, Acceleraet Phenotest BC Kit | Accelerate Diagnostics | DEN160032, DEN160032/S001 |
Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | K152470, K152470/S001 | |
hemoFISH Masterpanel | Miacom Diagnostics GMBH | K150031, K150031/S001 | |
IC-GPC Assay for use on the IC-System (positive blood cultures) | iCubate, Inc. | K163390, K163390/S001 | |
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | K122514, K113450 | |
Xpert Carba-R (GNR) | Cepheid | K152614, K152614/S001, K160901 (Rectal Swabs) | |
EPLEX BLOOD CULTURE IDENTIFICATION PANEL – GRAM POSITIVE (BCID-GP) PANEL | GENMARK DIAGNOSTICS, INCORPORATED | K181663 | |
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel | GenMark Diagnostics, Incorporated | K182619 | |
IC-GN IC-Cassette For Use On The IC-System | ICubate, Inc. | K190341 | |
Gram-Positive / Gram-Negative Bacteria (Antimicrobial resistance) | XPERT CARBA-R | CEPHEID | K173263 |
Herpes Simplex Virus | Aptima Herpes Simpex Viruses 1 & 2 | Hologic, Inc. | K162673, K162673/S001 |
ARIES HSV 1&2 Assay Cassettes – Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit | Luminex Corporation | K151906 | |
ARIES System | Luminex Corporation | K160517, K160517/S001 | |
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD) | Luminex Corporation | K161495 | |
IsoAmp HSV Assay | BioHelix Corporation | K111951 | |
MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit | EraGen Biosciences, Inc. | K111527, K100336 | |
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays | BD Diagnostic Systems | K103798 | |
SIMPLEXA HSV 1&2 DIRECT | FOCUS DIAGNOSTICS | K133621 (DEN130049) | |
AMIPLIVUE HSV 1&2 ASSAY | QUIDEL CORPORATION | K140029 | |
IMDX HSV-1/2 FOR ABBOTT M2000 | INTELLIGENT MEDICAL, INC. | K140198 | |
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | FOCUS DIAGNOSTICS | K141458, K151565, K151565/S001 | |
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control Pack | DIASORIN MOLECULAR LLC | K173798 | |
Solana HSV 1+2/VZV Assay | Quidel Corporation | K162451 | |
ARTUS HSV-1/2 QS-RGQ MDx KIT | QIAGEN | K142738 | |
SEEGENE ANYPLEX II HSV-1/2 ASSAY | SEEGENE | K142156 | |
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | DIAGNOSTIC HYBRIDS INC. | K133448 (DEN140004) | |
SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TEST | VELA DIAGNOSTICS USA INC. | K172509 | |
HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUS | ELITECHGROUP | K180559 | |
Hepatitis virus | Abbott RealTime HCV Genotype II | Abbott Molecular, Inc. | P120012 S001-S0016 |
Abbott Realtime HCV Assay | Abbott Molecular, Inc. | P100017 S001-S006, S007-S012, S014-S019 | |
Abbott Realtime HBV Assay | Abbott Molecular, Inc. | P080026 S001-S004, S005-S014, S016-S020 | |
Aptima HCV Quant Dx Assay | Hologic, Inc. | P160023 | |
COBAS HBV Test | Roche Molecular Systems | P150014 S001-S008 | |
COBAS HCV Test | Roche Molecular Systems | P160016 | |
COBAS HCV Test | Roche Molecular Systems | P150015 S001-S007 | |
COBAS AmpliPrep/COBAS TaqMan HCV test | Roche Molecular Systems | P060030 S001-S032, S033-S047, S048-S058 | |
COBAS Taqman HBV Test | Roche Molecular Systems, Inc. | P050028 S001-S027, S028-S047, S048, S050-S057 | |
Versant HCV 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics | P020022 | |
Versant HCV RNA Qualitative Assay | Gen-Probe, Inc. | P020011 S001-S007, S008, S009 | |
COBAS AMPLICOR Hepatitis C Virus (HCV) Test | Roche Molecular Systems, Inc. | P000012 S001-S043, S044-S053, S054-S056 | |
AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. | P000010 S001-S024 | |
APTIMA HBV QUANT ASSAY | HOLOGIC, INC | P170025 | |
Human Metapneumovirus | Pro hMPV+ Assay | Gen-Probe Prodesse, Inc. | K132200, K082688, K123838 |
Quidel Molecular hMPV Assay | Quidel Corporation | K112490 | |
Quidel Molecular RSV + hMPV Assay | Quidel Corporation | K131813, K122189 | |
Human papillomavirus | APTIMA HPV 16 18/45 Genotype Assay | Gen-Probe, Inc. | P120007 S001-S010 |
APTIMA HPV Assay | Gen-Probe, Inc. | P100042 S001-S012 | |
Cervista HPV 16/18 | Hologic, Inc. | P080015 S001-S012 | |
Cervista HPV HR and Genfind DNA Extraction Kit | Hologic, Inc. | P080014 S001-S018 | |
COBAS HPV Test | Roche Molecular Systems, Inc. | P100020 S001-S024 | |
Digene Hybrid Capture 2 High-Risk HPV DNA Test | Digene Corporation | P890064 S001-S034 | |
BD ONCLARITY HPV ASSAY | BECTON, DICKINSON AND COMPANY | P160037 | |
Influenza and Respiratory Viruses | PLEX-ID Flu assay | Abbott Laboratories | K121003 |
Alere i Influenza A & B | ALERE SCARBOROUGH, INC D/B/A BINAX, INC | K141520, K151464, K151690, K163266 | |
Alere i RSV | Alere Scarborough, Inc. | K161375 | |
ARIES Flu A/B & RSV Assay | Luminex Corporation | K161220 | |
artus Infl A/B RG RT-PCR Kit | Qiagen GmbH | K113323 | |
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | K080570 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | K133869, K132508, K130551, K123905, K111507, K161556 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Centers for Disease Control and Prevention | K161556 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit | Centers for Disease Control and Prevention | K172091 | |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPING | CENTERS FOR DISEASE CONTROL AND PREVENTION | K141859, K153148 | |
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | K101564 | |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit | Centers for Disease Control and Prevention | K181736 | |
XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IV | Cepheid | K180218 | |
ACCULA RSV TEST | MESA BIOTECH, INC. | K181443 | |
BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc | K192485 | |
cobas Liat Influenza A/B & RSV | Iquum, Inc. | K153544, K153544/S001 | |
ePlex Respiratory Pathogen Panel | GenMark Diagnostics, Inc | K163636, K163636/S001 | |
eSensor Respiratory Viral Panel (RVP) | Clinical Micro Sensors, Inc. | K113731 | |
FilmArray Respiratory Panel (RP) | Idaho Technology, Inc. | K120267, K110764, K103175 | |
FilmArray Respiratory Panel (RP) | BioFire Diagnostics, LLC | K123620, K143080, K160068 | |
FilmArray Respiratory Panel 2 (RP2) | BioFire Diagnostics, LLC | K170604 | |
FilmArray Respiratory Panel EZ (RP EZ) | BioFire Diagnostics, LLC | K152579, K152579/S001, K152579/S002 | |
FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | K161573 | |
Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | K163628, K163629, K163630 | |
IMDx Flu A/B and RSV for Abbott m2000 | Intelligent Medical Devices, Inc. | K131584 | |
INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | CENTERS FOR DISEASE CONTROL AND PREVENTION | K140851 | |
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | K060159 | |
INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | CENTERS FOR DISEASE CONTROL AND PREVENTION | K140857 | |
JBAIDS Influenza A Subtyping Kit | U.S. Army Medical Materiel Development Activity | K111778 | |
JBAIDS Influenza A&B Detection Kit | U.S. Army Medical Materiel Development Activity | K111775, K152523 | |
JBAIDS Influenza A/H5 (Asian lineage) Detection Kit | U.S. Army Medical Materiel Development Activity | K100287 | |
Liat Influenza A/B Assay | IQuum, Inc. | K111387 | |
LYRA PARAINFLUENZA VIRUS ASSAY | QUIDEL CORPORATION | K141927 | |
NxTAG Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | K152386, K152386/S001 | |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | K193167 | |
Prodesse ProFAST Assay | Gen-Probe Prodesse, Inc. | K132237 | |
Prodesse ProFlu + Assay | Gen-Probe Prodesse, Inc. | K132129 | |
Prodesse ProParaflu Assay | Gen-Probe Prodesse, Inc. | K132238, K091053 | |
Prodesse ProParaflu Assay | Hologic/Gen-Probe Prodesse, Inc. | K153223, K132238 | |
ProFlu+ Assay | Hologic/Gen-Probe Prodesse, Inc. | K153219, K110968, K092500, K081030, K073029 | |
ProParaFlu + Assay | Prodesse, Inc. | K091053 | |
Quidel Molecular Influenza A + B Assay | Quidel Corporation | K131728, K113777, K112172 | |
Simplexa Flu A/B & RSV | Focus Diagnostics, Inc. | K102170 | |
Simplexa Flu A/B & RSV Direct | Focus Diagnostics, Inc. | K120413, K142365, K152408 | |
Simplexa Influenza A H1N1 (2009) | Focus Diagnostics, Inc . | K100148 | |
Solana Influenza A+B Assay | Quidel Corporation | K161814 | |
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nanosphere, Inc. | K143653, K143653/S001 | |
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) | Nanosphere, Inc. | K103209, K093337, K092957, K092566, K083088 | |
Xpert Xpress Flu | Cepheid | K162456, K162456/S001, K171552 | |
Xpert Flu + RSV Xpress | Cepheid | K151226, K162331, K162331/S001 | |
Xpert Flu Assay | Cepheid | K123191, K120911, K103766 | |
XPERT FLU/RSV XC ASSAY | Cepheid | K142045 | |
XPERT XPRESS FLU, XPERT NASOPHARYNGEAL SAMPLE COLLECTION KIT, XPERT NASAL SAMPLE COLLECTION KIT, GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI), GENEXPERT INFINITY-48S SYSTEM AND GENEXPERT INFINITY-80 SYSTEM | Cepheid | K181289 | |
xTAG Respiratory Viral Panel (RVP) | Luminex Molecular Diagnostics, Inc. | K112781, K112199, K091667, K081483, K063765 | |
xTAG Respiratory Viral Panel Fast (RVP FAST) | Luminex Molecular Diagnostics, Inc. | K103776 | |
ACCULA FLU A/FLU B TEST | MESA BIOTECH, INC. | K171641 | |
Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | K171792 | |
FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | K173171 | |
FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS) | BIOFIRE DIAGNOSTICS, LLC | DEN170017 | |
Panther Fusion AdV/HMPV/RV Assay | Hologic, Inc. | K172629 | |
Panther Fusion Paraflu Assay | Hologic, Inc. | K172282 | |
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther | Hologic, Inc. | K171963 | |
Solana RSV+HMPV Assay | Quidel Corporation | K171974 | |
ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | K190204 | |
ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | K191534 | |
Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System | Roche Molecular Systems, Inc | K191729 | |
FluChip-8G Influenza A+B Assay | InDevR, Inc | K182513 | |
Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A/B Typing Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr, Influenza B Lineage Genotyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr, | Centers For Disease Control And Prevention | K190302 | |
Influenza and Respiratory Viruses Influenza A & B, Strep A, RSV | ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 2 | Alere Scarborough, Inc. | K173932 |
ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 4 | Alere Scarborough, Inc. | K173932 | |
ALERE I STREP A 2, ALERE I INSTRUMENT, ALERE I STREP A 2 CONTROL SWAB KIT | Alere Scarborough, Inc. | K173653 | |
Respiratory panel control material | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | K190086 |
Respiratory panel | QIAstat-Dx Respiratory Panel; QIAstat-Dx Analyzer | QIAGEN GmbH | |
Leishmaniaspecies | SMART Leish | U.S. Army Medical Materiel Development Activity | K081868 |
Meningitis/Encephalitis | FilmArray Meningitis/Encephalitis(ME) Panel | BioFire Diagnostics LLC | DEN150013, DEN150013/S001, K160462 |
Mycobacterium tuberculosis | Xpert MTB/RIF Assay | Cepheid | K131706 |
BDProbetec ET Mycobacterium tuberculosis complex culture identification kit | Becton, Dickinson, & Co. | K000884 | |
Amplified Mycobacterium tuberculosis Direct Test | Gen-Probe, Inc. | P940034 | |
Amplicor Mycobacterium tuberculosis test | Roche Molecular Systems, Inc. | P940040 | |
SNAP M.tuberculosis complex | Syngene, Inc. | K900292 | |
Accuprobe Mycobacterium tuberculosis complex Test | Gen-Probe, Inc. | K896493 | |
Rapid Diagnostic System for Mycobacterium tuberculosis | Gen-Probe, Inc. | K871795 | |
Rapid Identification Test for Mycobacterium tuberculosis complex | Gen-Probe, Inc. | K862614 | |
Mycobacterium species | Accuprobe Mycobacterium avium complex culture | Gen-Probe, Inc. | K921435, K896494, K897078 |
Accuprobe Mycobacterium kansasii Identification Test | Gen-Probe, Inc. | K904463 | |
SNAP Mycobacterium avium complex | Syngene, Inc. | K900202 | |
Accuprobe Mycobacterium intracellulare Culture Identification Test | Gen-Probe, Inc. | K897077 | |
Accuprobe Mycobacterium gordonae culture identification Test | Gen-Probe, Inc. | K896492 | |
Rapid Diagnostic System for Mycobacterium gordonae | Gen-Probe, Inc. | K890089 | |
Rapid Diagnostic System for Mycobacteria | Gen-Probe, Inc. | K864597 | |
Rapid Identification Test for Mycobacterium avium | Gen-Probe, Inc. | K862613 | |
Gen-Probe Mycobacterium Rapid Confirmation System | Gen-Probe, Inc. | K860782 | |
Mycoplasma Genitalium | Aptima Mycoplasma Genitalium Assay | Hologic, Inc. | DEN180047 |
Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) | Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | K190433 |
Mycoplasma pneumoniae | illumigene Mycoplasma Direct DNA Amplification Assay | Meridian Bioscience, Inc. | K160829 |
illumigene Mycoplasma DNA Amplification Assay | Meridian Bioscience, Inc. | K152800, K123423 | |
Multiplex Panel | BD Max Vaginal Panel, BD MAX Instrument | GeneOhm Sciences Canada | DEN160001/ DEN160001/S001 |
BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP) | APPLIED BIOCODE, INC. | K180041 | |
Curetis Unyvero LRT Application | Curetis GmbH | DEN170047 | |
Unyvero LRT BAL Application | Curetis GmbH | K191967 | |
ePlex instrument (multiplex) | GenMark Diagnostics, Inc | K163652, K163652/S001 | |
FilmArray BCID Panel | BioFire Defense, LLC | K143171, K160457 | |
FilmArray NGDS Warrior Panel | BioFire Defense, LLC | K170883, DEN160048 | |
FilmArray Warrior Control Panel | Maine Molecular Quality Controls, Inc. | K163522 | |
NEUMODX GBS ASSAY | NEUMODX MOLECULAR, INC. | K173725 | |
PANNAT STEC TEST | MICRONICS, INC | K173330 | |
ProGastro SSCS Assay | Gen-Probe Prodesse, Inc. | K123274 | |
Biocode Gastrointestinal Pathogen Panel (GPP) | Applied Biocode, Inc. | K190585 | |
EntericBio Dx Assay | Serosep, Ltd. | K182703 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K121894, K121454 | |
BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton Dickinson and Company | K170308 | |
BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENT | Becton Dickinson and Company | K181427 | |
FILMARRAY GASTROINTESTINAL (GI) PANEL | BIOFIRE DIAGNOSTICS | K140407, K160459, K160459/S001 | |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | K191160 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K191161 | |
Luminex Molecular Diagnostics, Inc. | K191160 | ||
T2BACTERIA PANEL | T2 BIOSYSTEMS, INC. | K172708 | |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | K191160 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K191161 | |
Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | K163571, K163571/S001 | |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS | LUMINEX MOLECULAR DIAGNOSTICS INC. | K140377, K140647 | |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) | NANOSPHERE, INC | K140083, K142033 | |
FILMARRAY PNEUMONIA PANEL | BioFire Diagnostics, LLC | K180966 | |
FILMARRAY PNEUMONIA PANEL PLUS | BioFire Diagnostics, LLC | K181324 | |
Multiplex Panel (Pneumonia) QC Material | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. (MMQCI) | K190222 |
Non-Variola Orthopoxvirus | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | K181205 |
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | DEN070001 | |
Norovirus | RIDA GENE Nororvirus GI/GII | R-Biopharm AB | K171511 |
XPERT NOROVIRUS GENEXPERT Dx SYSTEMS (GX-I GX-11 GX-IV GX-XVI) GENEXPERT INFINITY-48 SYSTEM, GENEXPERT INFINITY-48S SYSTEM, GENEXPERT INFINITY-80 SYSTEM | CEPHEID | K142501 | |
Plasmodium | ID-FISH Plasmodium Genus Test Kit, ID-FISh P. falciparum and P. vivax Combo Test | ID-FISH Technology, Inc. | DEN160025, DEN160025/S001 |
Rickettsia | Rickettsia Real-time PCR Assay | Centers for Disease Control and Prevention | K170940 |
Sepsis | SeptiCyte LAB | Immunexpress, Inc. | K163260 |
Staphylococcus | BD Max MRSA Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K120138 |
Staphylococcus QuickFISH BC | AdvanDx, Inc. | K113371 | |
MRSA/SA ELITe MGB | EliTechGroup Epoch Biosciences. | K112937, K132468 | |
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test | Nanosphere, Inc. | K112424 | |
NucliSENS EasyQ MRSA Assay | bioMerieux, Inc. | K102740 | |
Xpert MRSA/SA Blood Culture Assay | Cepheid | K101879, K082140 | |
Xpert MRSA/SA Nasal Complete Assay | Cepheid | K100822 | |
LightCycler MRSA Advanced Test | Roche Molecular Systems, Inc | K091409 | |
BD GeneOhm MRSA ACP Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K093346 | |
S. aureus and/or other Staphylococcus species PNA FISH Culture | AdvanDx, Inc. | K092166 | |
Xpert MRSA/SA SSTI Assay | Cepheid | K080837 | |
BD GeneOhM StaphSR Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K071026 | |
S. aureus PNA FISH | AdvanDx, Inc. | K091827, K060099 | |
Xpert MRSA | Cepheid | K070462 | |
IDI-MRSA Assay | Infectio Diagnostic, Inc. | K042357, K033415 | |
MECA XPRESSFISH | ADVANDX INC. | K140619 | |
COBAS MRSA/SA TEST | ROCHE MOLECULAR SYSTEMS INC. | K142721 | |
Xpert MRSA NxG | Cepheid | K162444 | |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | K190771 | |
Staphylococcus / MRSA Control Material | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | K191172 |
Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | K191168 | |
Streptococci | ARIES GBS Assay | Luminex Corporation | K162772 |
Xpert GBS LB Assay | Cepheid | K121539 | |
illumigene Group A Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K122019 | |
illumigene Group B Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K121044 | |
BD Max GBS Assay | Becton, Dickinson, & Co. | K111860 | |
Cepheid Smart GBS Assay | Cepheid | K062948 | |
Xpert GBS | Cepheid | K060540 | |
IDI-Strep B Assay | Infectio Diagnostic, Inc. | K022504 | |
Gen-Probe Accuprobe Group B Streptococcus culture identification kit | Chugai Pharmaceuticals Co, Ltd. | K974572 | |
Accuprobe Streptococcus pneumoniae culture confirmation | Gen-Probe, Inc. | K902908 | |
ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAY | MERIDIAN BIOSCIENCE, INC. | K112125 | |
AMPLIVUE GBS ASSAY | QUIDEL CORPORATION | K133503 | |
LYRA DIRECT STREP ASSAY | QUIDEL CORPORATION | K133883 (DEN140005) | |
AMPLIVUE GAS ASSAY | QUIDEL CORPORATION | K141173 | |
LIAT STREP A ASSAY | IQUUM INC | K141338 | |
revogene | GenePOC Inc. | K170558 | |
GenePOC GBS LB | GenePOC Inc. | K170557 | |
Solana Strep Complete Assay | Quidel Corporation | K162274 | |
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation | K172402 | |
Xpert Xpress Strep A | Cepheid | K172126; K173398 | |
GenePOC Strep A | GenePOC Inc. | K183366 | |
Streptococci / GBS Conrol Material | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | K182472 |
Shiga Toxin | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | K152955, K152955/S001, K152955/S002 |
Trichomonas vaginalis | Affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis | Microprobe Corp. | K923133 |
Amplivue Trichomonas Assay | Quidel Corporation | K143329 | |
APTIMA Trichomonas vaginalis (ATV) Assay | Gen-Probe, Inc. | K102911 | |
APTIMA Trichomonas vaginalis Assay (PANTHER System) | Gen-Probe, Inc. | K122062 | |
BD ProbeTec Trichomonas vaginalis (TV) QX Amplified DNA Assay | Becton, Dickinson & Co. | K130268 | |
Solana Trichomonas Assay | Quidel Corporation | K161182, K161182/S001 | |
Xpert TV | Cepheid | K151565, K151565/S001, K161619 | |
Transport Media | PRIMESTORE MTM | Longhorn Vaccines and Diagnostics LLC | DEN170029 |
Vaginal Panel (Bacterial vaginosis vaginitis) | BD MAX Vaginal Panel | GeneOhm Sciences Canada, Inc. (BD Diagnostics) | DEN160001 |
Varicella-zoster viruses | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | DiaSorin | K192376 |
Variola | Variola Virus Real-Time PCR Assay | Centers for Disease Control and Prevention | DEN160016, DEN160016/S001 |
Yersinia pestis | JBAIDS Plague Detection Kit |
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