Cotinine (COT) Rapid Test Cassette DCT-102

GUDID 06970277512503

Cotinine (COT) Rapid Test Cassette Box of 40

Hangzhou AllTest Biotech Co., Ltd.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06970277512503
NIH Device Record Key655f5020-d659-44ef-b1df-818c3bf5a28e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCotinine (COT) Rapid Test Cassette
Version Model NumberDCT-102
Catalog NumberDCT-102
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count40
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970277512497 [Unit of Use]
GS106970277512503 [Primary]

FDA Product Code

MRSTest System, Nicotine, Cotinine, Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-09
Device Publish Date2018-09-08

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

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