2,476 results · 70ms · Sources: EU EUDAMED, US FDA

LIQUICHEK BNP CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LYPHOCHEK ASSAYED CHEMISTRY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

FDA 510(k)
FDA Class 2 ·Microbiology

ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR

FDA 510(k)
FDA Class 2 ·Immunology

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VARIANT II HEMOGLOBIN A1C

FDA 510(k)
FDA Class 2 ·Hematology

ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

KALLESTAD RSV MICROPLATE EIA

FDA 510(k)
FDA Class 1 ·Microbiology

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCESS CHLAMYDIA ASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

ACCESS MYOGLOBIN REAGENTS

FDA 510(k)
FDA Class 2 ·Immunology

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

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