AIMTAB BILIRUBIN TABLETS

GUDID 00695684132002

AimTab™ Bilirubin Tablets will detect as little as 0.05 to 0.1 mg/dL (0.8 to 1.7 µmol/L) bilirubin in urine.

GERMAINE LABORATORIES, INC

Total bilirubin IVD, reagent
Primary Device ID00695684132002
NIH Device Record Key4cf60763-e10d-4e67-b54d-4987b01f3bb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMTAB BILIRUBIN TABLETS
Version Model Number13200
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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
GS100695684132001 [Unit of Use]
GS100695684132002 [Primary]

FDA Product Code

CIGDiazo Colorimetry, Bilirubin

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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