230 results
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32ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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QUANTAPHASE B-12-COBALMIN-FOLATE-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COTUBE PTH IRMA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
FDA 510(k)
FDA Class 2
·Hematology
DIGILAB MODULAR ONE-APPLANATION TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
FDA 510(k)
FDA Class 2
·Immunology
BIOPLEX 2200 MMRV IGG
FDA 510(k)
FDA Class 2
·Microbiology
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
FDA 510(k)
FDA Class 2
·Microbiology
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
FDA 510(k)
FDA Class 2
·Hematology
BioPlex 2200 Lyme Total
FDA 510(k)
FDA Class 2
·Microbiology
MONOLISA ANTI-HAV EIA
FDA 510(k)
FDA Class 2
·Microbiology
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONOLISA ANTI-HAV IGM EIA
FDA 510(k)
FDA Class 2
·Microbiology
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
FDA 510(k)
FDA Class 2
·Microbiology
BIOPLEX VASCULITIS KIT
FDA 510(k)
FDA Class 2
·Immunology
ANA-SCREEN WITH MDSS
FDA 510(k)
FDA Class 2
·Immunology
BIOPLEX 2200 APLS IGM
FDA 510(k)
FDA Class 2
·Immunology
MULTI-ANALYTE DETECTION SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
PLATELIA TOXO IGM KIT MODEL 26211
FDA 510(k)
FDA Class 2
·Microbiology