Cotinine (COT) Rapid Test Dipstick DCT-101

GUDID 06970277512541

Cotinine (COT) Rapid Test Dipstick Box of 50

Hangzhou AllTest Biotech Co., Ltd.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06970277512541
NIH Device Record Key7477e7c4-42b0-47d2-bca0-bc2dd8fe3518
Commercial Distribution StatusIn Commercial Distribution
Brand NameCotinine (COT) Rapid Test Dipstick
Version Model NumberDCT-101
Catalog NumberDCT-101
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count50
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
GS106970277512534 [Unit of Use]
GS106970277512541 [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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