CERTUM COC One Step Cocaine Test Strip

GUDID 10810124273733

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10810124273733
NIH Device Record Key28fc87f7-b8f7-4592-a17b-c8042689a0ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERTUM COC One Step Cocaine Test Strip
Version Model NumberDCO-101-a-Sgl
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count50
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810124273736 [Primary]
GS110810124273733 [Unit of Use]

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

On-Brand Devices [CERTUM COC One Step Cocaine Test Strip]

10810124273740DCO-U101-a-Sgl
10810124273733DCO-101-a-Sgl

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