Cotinine (COT) Rapid Test Panel DCT-114

GUDID 06970277512527

Cotinine (COT) Rapid Test Panel box of 40

Hangzhou AllTest Biotech Co., Ltd.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06970277512527
NIH Device Record Keyadca989b-3b04-449f-a82d-4f8cb06e8871
Commercial Distribution StatusIn Commercial Distribution
Brand NameCotinine (COT) Rapid Test Panel
Version Model NumberDCT-114
Catalog NumberDCT-114
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
GS106970277512510 [Unit of Use]
GS106970277512527 [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 Date2018-10-11
Device Publish Date2018-09-10

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