AIMSTRIP US-11

GUDID 00695684511111

GERMAINE LABORATORIES, INC

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid
Primary Device ID00695684511111
NIH Device Record Key8a82a249-e608-46c8-bc96-b6447c9a5bd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSTRIP US-11
Version Model Number51111
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count100
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
GS100695684511111 [Primary]
GS100695684511112 [Unit of Use]

FDA Product Code

LJXTest, Urine Leukocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2016-04-27

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