Microbiology
FDA medical specialty panel: Microbiology. Product code prefix: MI.
26 companies · 178 devicesElecsys Anti-HCV II (08837031190) (K221693)
Class Class II K221693 MZO
Selux AST System; Model AST Gen 1.0 (K211759)
Class Class II K211759 LON
Biosci Inactivated Transport Medium, Biosci ITM (K220059)
Class Class II K220059 QBD
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)
Class Class II K221899 NGZ
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)
Class Class II K223016 PSZ
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 – =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 – =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803)
Class Class II K220803 LON
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481)
Class Class II K223481 LON
Active Anthrax DetectTM Plus Rapid Test (DEN220044)
Class Class II DEN220044 QUU
BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954)
Class Class II K213954 QOF
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253)
Class Class II K221253 PMN
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)
Class Class II K222073 LON
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)
Class Class II K223478 LON
Spectrum Saliva Collection Device (K223497)
Class Class II K223497 QBD
Alinity m STI Assay (K222379)
Class Class II K222379 QEP
Lyra Influenza A+B Assay (K230236)
Class Class II K230236 OZE
BD Vaginal Panel (K223653)
Class Class II K223653 PQA
Visby Medical Sexual Health Test (K220407)
Class Class II K220407 QEP
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039)
Class Class II DEN220039 QVF
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)
Class Class II K222430 LON
Lyra RSV+hMPV Assay (K230349)
Class Class II K230349 OEM
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)
Class Class II K221198 NGZ
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404)
Class Class II K230404 PCH
Access PCT (K222996)
Class Class II K222996 PTF
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743)
Class Class I K212743 JSM
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