UA LIQUID CONTROLS 6X10ML

GUDID 00695684511616

Liquid Controls ready to use for AimStrip® Urine Reagent Strips

GERMAINE LABORATORIES, INC

Multiple urine analyte IVD, control
Primary Device ID00695684511616
NIH Device Record Keya4973d43-9a3a-4ad1-a32f-069edf95f73c
Commercial Distribution StatusIn Commercial Distribution
Brand NameUA LIQUID CONTROLS 6X10ML
Version Model Number51161
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count6
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
GS100695684511611 [Unit of Use]
GS100695684511616 [Primary]

FDA Product Code

JJWUrinalysis Controls (Assayed And Unassayed)

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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