AIMSCREEN MOP

GUDID 00695684481254

Lateral flow immunoassay for the detection of Opiate (OPI) in urine.

GERMAINE LABORATORIES, INC

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)
Primary Device ID00695684481254
NIH Device Record Key0f7014a0-3a23-4e0d-be1a-c9d2b0b52c74
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSCREEN MOP
Version Model Number48125
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
GS100695684481251 [Unit of Use]
GS100695684481254 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

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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