AIM RPR TEST

GUDID 00695684365004

Test for reagin antibodies in serum or plasma

GERMAINE LABORATORIES, INC

Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00695684365004
NIH Device Record Keyba1a94b1-ec01-44c3-bb75-9f89307d38b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIM RPR TEST
Version Model Number36500
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count500
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
GS100695684365001 [Unit of Use]
GS100695684365004 [Primary]

FDA Product Code

GMQAntigens, Nontreponemal, All

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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