AIM ASO TEST

GUDID 00695684310509

Latex test for Anti-streptolysin O

GERMAINE LABORATORIES, INC

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Primary Device ID00695684310509
NIH Device Record Key458aa0fa-ff88-464c-bdd3-4056e7a2a486
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIM ASO TEST
Version Model Number31050
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count50
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
GS100695684310501 [Unit of Use]
GS100695684310509 [Primary]

FDA Product Code

GTQAntistreptolysin - Titer/Streptolysin O Reagent

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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