2,476 results · 65ms · Sources: EU EUDAMED, US FDA

LIQUID ASSAYED MULTIQUAL PREMIUM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

FDA 510(k)
FDA Class 2 ·Microbiology

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

FDA 510(k)
FDA Class 2 ·Microbiology

LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK TUMOR MARKER CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

FDA 510(k)
FDA Class 2 ·Immunology

BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)
FDA Class 2 ·Microbiology

BioPlex 2200 25-OH Vitamin D Kit

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AMP One Step Amphetamine Single Drug Test (Urine)

FDA registration
ABON BIOPHARM (HANGZHOU) CO., LTD.·1 product·🇨🇳 China

AMP One Step Amphetamine Single Drug Test (Urine)

FDA registration
Alere San Diego, Inc.·1 product·🇺🇸 United States

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK TORCH PLUS IGM CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCESS PROLACTIN

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

FDA 510(k)
FDA Class 2 ·Hematology