FIRSTVIEW Cocaine(COC) Urine Test Dipcard COC-1014

GUDID 06974246460857

Safecare Biotech (Hangzhou) Co., Ltd.

Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Primary Device ID06974246460857
NIH Device Record Key9162ef62-0d07-4dad-8935-6663390b50dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIRSTVIEW Cocaine(COC) Urine Test Dipcard
Version Model NumberCOC-1014
Catalog NumberCOC-1014
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS106974246460857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-03
Device Publish Date2023-12-26

Devices Manufactured by Safecare Biotech (Hangzhou) Co., Ltd.

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