6,468 results · 45ms · Sources: EU EUDAMED, US FDA

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH 2 BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER

Colorimetry, Salicylate

FDA classification
FDA Class 2 ·Colorimetry, Salicylate

Enzymatic Method, Ammonia

FDA classification
FDA Class 1 ·Enzymatic Method, Ammonia

Colorimetry, Acetaminophen

FDA classification
FDA Class 2 ·Colorimetry, Acetaminophen

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT IMX TOTAL PSA

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA classification
FDA Class 2 ·Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

FDA classification
FDA Class 2 ·Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Azo Dye, Calcium

FDA classification
FDA Class 2 ·Azo Dye, Calcium

Catalytic Methods, Amylase

FDA classification
FDA Class 2 ·Catalytic Methods, Amylase

RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CANNABINOID URINE CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS CALCHECK TESTOSTERONE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry