48 results · 78ms · Sources: EU EUDAMED, US FDA

Catachem

FDA registration
CATACHEM, INC.·3 products·🇺🇸 United States

Catachem DiscretPak™

FDA UDI
CATACHEM, INC.·00853618007011·Bile Acids (Colormetric) Kit C

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

URIC ACID (URICASE) METHOD-II

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS

FDA 510(k)
FDA Class 1 ·Hematology

CHOLESTEROL METHOD

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ASPARTATE AMINOTRANSFERASE (AST)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIRECT BILIRUBIN FOR CONTINUOUS FLOW

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BACTON TM, BASIC TM, APO A-I REAGENT

FDA 510(k)
FDA Class 1 ·Immunology

LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALANINE AMINOTRANSFERASE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry