CERTUM AMP One Step Amphetamine Test Strip

GUDID 10810124273702

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10810124273702
NIH Device Record Key6cbf22a2-8c88-49d0-8c09-8e1b984d1200
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERTUM AMP One Step Amphetamine Test Strip
Version Model NumberDAM-A101-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
GS100810124273705 [Primary]
GS110810124273702 [Unit of Use]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

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 AMP One Step Amphetamine Test Strip]

10810124273702DAM-A101-a-Sgl
10810124273696DAM-101-a-Sgl

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