401 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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BASELINE CALIBRATION VERIFICATION CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
FDA 510(k)
FDA Class 2
·Microbiology
FLIPSCREEN QAT
FDA 510(k)
FDA Class 2
·Immunology
EQUATE(TM) AQR APO AL/B DUO CONTROL
FDA 510(k)
FDA Class 2
·Immunology
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
FDA 510(k)
FDA Class 2
·Microbiology
BINAX EQUATE GLYCOHEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
BinaxNOW COVID-19 Antigen Self Test; BinaxNOW COVID-19 Ag Card
FDA 510(k)
FDA Class 2
·Microbiology
MICROCO
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTRESCREEN HCG URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALERE PBP2A TEST
FDA 510(k)
FDA Class 2
·Microbiology
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
FDA 510(k)
FDA Class 2
·Immunology
VENTREX COATED TUBE T3 UPTAKE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
BINAXNOW INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray BCID2 Control Panel M416
FDA 510(k)
FDA Class 2
·Microbiology
microTargeting Guideline 4000 5.0 System
FDA 510(k)
FDA Class 2
·Neurology
BINAX IRMA TOTAL BETA-HCG TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FHC MICROTARGETING DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ALERE I STREP A
FDA 510(k)
FDA Class 2
·Microbiology