AIM CRP TEST

GUDID 00695684321000

Latex slide test for C Reactive Protein

GERMAINE LABORATORIES, INC

C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Primary Device ID00695684321000
NIH Device Record Key7adc35a5-549e-4856-bc15-00a4b5b0c913
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIM CRP TEST
Version Model Number32100
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
GS100695684321000 [Primary]
GS100695684321001 [Unit of Use]

FDA Product Code

DCNSystem, Test, C-Reactive Protein

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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