Home GUDID 10816467020034 FastPack® Testo Kit (50)
Primary DI 10816467020034
Brand FastPack® Testo Kit (50)
Company QUALIGEN INC.
Model Testo Immunoassay
Catalog number 25000009
Device description 50 Test Non-Ported Testo Immunoassay Kit
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10816467020034 Primary GS1 0 00816467020037 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10816467020034 10816467020034 00816467020037 00816467020037 816467020037 0816467020037
GMDN Terms# Term, Definition table Term Definition Total testosterone IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen, using a chemiluminescent immunoassay 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 959103565 Device count 50 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816467020396 FastPack® IP System IP System 08000043-A, 08000043-AR 2024-09-27 00816467020402 FastPack® IP System IP System 08000043-X2 2024-09-27 10816467020126 FastPack® IP hCG Kit (30) hCG Immunoassay 25000044 2016-09-16 00816467020105 Calibrator Kit – hCG hCG Cal 25000035 2016-09-16 00816467020112 FastPack® IP hCG Diluent Kit (25) hCG Diluent 25000036 2016-09-16 20816467020031 FastPack® IP Testo Kit (30) Testo Immunoassay 25000041 2016-09-16 30816467020038 FastPack® IP Testo Kit (90) Testo Immunoassay 25000058 2017-09-14 00816467020044 Calibrator Kit - Testosterone Testo Cal 25000014 2016-09-16 00816467020136 FastPack® Control Kit Multi-Analyte Controls 25000056 2016-09-16 00816467020372 FastPack® Pro System Pro System 08000067, 08000067-R, 08000067-X 2020-08-05 00816467020006 FastPack® IP System IP System 08000043, 08000043-R, 08000043-X 2016-09-16 00816467020334 FastPack® IP System IP System 08000043-C, 08000043-CR 2016-09-16 10816467020386 FastPack SARS-CoV-2 IgG SARS-CoV-2 IgG Immunoassay 25000085 2020-08-05 00816467020389 FastPack SARS-CoV-2 IgG SARS-CoV-2 IgG Immunoassay 25000085 2020-08-05 10816467020010 FastPack® Total PSA Kit (50) TPSA Immunoassay 25000001 2016-09-16 20816467020017 FastPack® IP Total PSA Kit (30) TPSA Immunoassay 25000040 2016-09-16 30816467020014 FastPack® IP Total PSA Kit (90) TPSA Immunoassay 25000057 2017-09-14 00816467020020 Calibrator Kit - PSA TPSA Cal 25000002 2016-09-16 00816467020075 Method Verification Kit - PSA TPSA Verifier 25000017 2016-09-16 00816467020167 Control Kit - PSA PSA Controls 25000003 2016-09-16
Other Devices Sharing Product Codes# 
qualigeninc.com