AimScreen Fentanyl

GUDID 10695684423381

GERMAINE LABORATORIES, INC

Fentanyl IVD, kit, rapid ICT, clinical
Primary Device ID10695684423381
NIH Device Record Keyd7a738ff-9b6d-4e6f-885c-feceeef39b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameAimScreen Fentanyl
Version Model Number42338
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 Kittrue
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684423384 [Primary]
GS110695684423381 [Unit of Use]

FDA Product Code

NGLTest, Opiates, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

Devices Manufactured by GERMAINE LABORATORIES, INC

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06956847540756 - Mosie Baby Ovulation Test2019-10-29 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel

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