AIMSCREEN MET

GUDID 00695684471255

Lateral flow immunoassay for the detection of Methamphetamine (MET) in urine.

GERMAINE LABORATORIES, INC

Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid
Primary Device ID00695684471255
NIH Device Record Key7b7b9995-6253-4954-a96a-e275942a2877
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSCREEN MET
Version Model Number47125
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 Datefalse
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
GS100695684471251 [Unit of Use]
GS100695684471255 [Primary]

FDA Product Code

LAFGas Chromatography, Methamphetamine

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 Date2016-05-04

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