AIMSCREEN AMP

GUDID 00695684411251

Lateral flow immunoassay for the detection of Amphetamine (AMP) in urine.

GERMAINE LABORATORIES, INC

Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00695684411251
NIH Device Record Keyb9aa01ad-dc47-4a87-a082-6b50888fdb4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSCREEN AMP
Version Model Number41125
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count25
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684411251 [Primary]
GS100695684411252 [Unit of Use]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-05-11

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