230 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ACCESS ALLERGEN DOG EPITHELIM
FDA 510(k)
FDA Class 2
·Immunology
ACCESS TOTAL BHCG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
FDA 510(k)
FDA Class 2
·Hematology
KALESTAD ANA MICROPLATE EIA
FDA 510(k)
FDA Class 2
·Immunology
ACCESS TOTAL T3 ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II TURBO HbA1c Kit - 2.0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-10 Hemoglobin A1c Program
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
FDA 510(k)
FDA Class 2
·Immunology
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
FDA 510(k)
FDA Class 2
·Hematology
ACCESS CORTISOL REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
D-10 HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONOLISA ANTI-HAV EIA
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
D-100 HbA1c, D-100 HbA1c Calibrator Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS THYROID UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
FDA 510(k)
FDA Class 2
·Microbiology