AIMSTRIP US-4OB

GUDID 00695684541002

Dipstick reagent strips for the qualitative detection of the following : Glucose, Protein, Nitrite and Leukocytes in Urine.

GERMAINE LABORATORIES, INC

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Primary Device ID00695684541002
NIH Device Record Key6a67ac71-7e4f-4ea1-afcf-7622e869228a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSTRIP US-4OB
Version Model Number54100
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
GS100695684541001 [Unit of Use]
GS100695684541002 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-04-27

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