4,632 results · 43ms · Sources: EU EUDAMED, US FDA

ABBOTT ARCHITECT HAVAB-M

FDA 510(k)
FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)
FDA Class 2 ·Microbiology

STREPTO-SEC TM

FDA 510(k)
FDA Class 1 ·Microbiology

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

FDA 510(k)
FDA Class 1 ·Microbiology

Afinion HbA1c Dx on Afinion 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Tina-quant Hemoglobin A1cDx Gen.3

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TINA-QUANT HBA1C GEN. 2 TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SEKURE HbA1c Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HbA1c Advanced

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CAPI 3 Hb A1c

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Medconn Glycated Hemoglobin Test system

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CAPILLARYS Hb A1c

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO HbA1c Kit - 2.0

FDA 510(k)
FDA Class 2 ·Clinical Chemistry