10,000 results · 89ms · Sources: EU EUDAMED, US FDA

STRATUS CS CKMB CALPAK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RCRP FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

BEHRING COAGULATION SYSTEM (BCS)

FDA 510(k)
FDA Class 2 ·Hematology

EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N LATEX LP(A)

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE

FDA 510(k)
FDA Class 2 ·Microbiology

DADE BEHRING COAGULATION ANALYZER (BCT)

FDA 510(k)
FDA Class 2 ·Hematology

DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION ALDL CALIBRATOR, MODEL DC131

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN

FDA 510(k)
FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STRATUS CS D-DIMER

FDA 510(k)
FDA Class 2 ·Hematology

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IGG FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

EMIT II PLUS ECSTASY ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology