Home GUDID 00850392007152 BioCheck Testosterone EIA Test Kit
Primary DI 00850392007152
Brand BioCheck Testosterone EIA Test Kit
Company BIOCHECK, INC.
Model BC-1115
Catalog number BC-1115
Device description The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of testosterone concentration in human serum.
Published 2019-07-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850392007152 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850392007152 00850392007152 850392007152 0850392007152
GMDN Terms# Term, Definition table Term Definition Free testosterone IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the quantitative measurement of free testosterone in a clinical specimen, using an enzyme immunoassay (EIA) method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 171857493 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850392007015 BioCheck TSH EIA Test Kit BC-1001 BC-1001 2019-10-08 00850392007039 BioCheck U-TSH EIA Test Kit BC-1003 BC-1003 2019-10-08 00850392007053 BioCheck T3 EIA Test Kit BC-1005 BC-1005 2019-10-08 00850392007077 BioCheck T4 EIA Test Kit BC-1007 BC-1007 2019-10-08 00850392007176 BioCheck Myoglobin EIA Test Kit BC-1117 BC-1117 2019-10-08 00850392007190 BioCheck High Sensitive CRP EIA Test Kit BC-1119 BC-1119 2019-10-08 00850392007251 BioCheck Human Ferritin EIA Test Kit BC-1025 BC-1025 2019-10-08 00850392007275 BioCheck hCG EIA Test Kit BC-1027 BC-1027 2019-10-08 00850392007350 BioCheck IgE EIA Test Kit BC-1035 BC-1035 2019-10-08 00850392007619 BioCheck Beta-2 Microglobulin EIA Test Kit BC-1061 BC-1061 2019-10-08
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