230 results · 32ms · Sources: EU EUDAMED, US FDA

NOVAPATH TSH ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUANTA PHASE VITAMIN B-12/FOLATE RAD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MANUAL PHENYLALANINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RADIAS MONOCLONAL HBA 1C ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

FDA 510(k)
FDA Class 2 ·Immunology

VARIANT SICKLE CELL SHORT PROGRAM

FDA 510(k)
FDA Class 2 ·Hematology

LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206

FDA 510(k)
FDA Class 2 ·Immunology

ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01

FDA 510(k)
FDA Class 2 ·Immunology

VARIANT HEMOGLOBINOPATHY PROGRAM

FDA 510(k)
FDA Class 2 ·Hematology

HEMOGLOBIN ALC BY COLUMN TEST

FDA 510(k)
FDA Class 2 ·Hematology

BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MRSASelect II

FDA 510(k)
FDA Class 2 ·Microbiology

VARIANT ALPHA-THALASSEMIA SHORT PROGRAM

FDA 510(k)
FDA Class 2 ·Hematology

VRESELECT CULTURE MEDIUM

FDA 510(k)
FDA Class 2 ·Microbiology

LIQUICHEK RETICULOCYTE CONTROL (A)

FDA 510(k)
FDA Class 2 ·Hematology

RADIAS RED CELL FOLATE IMMUNOASAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

REMEDI HS DRUG PROFILING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

FLUOROMATIC THEOPHYLLINE FIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MRSASELECT - EXTENDED INCUBATION

FDA 510(k)
FDA Class 2 ·Microbiology