SALMONELLA H d ANTIGEN

GUDID 00695684014032

Febrile Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

GERMAINE LABORATORIES, INC

Salmonella typhi antigen IVD, kit, agglutination
Primary Device ID00695684014032
NIH Device Record Key10fefed7-e618-44f2-8ec1-3923c5727c11
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALMONELLA H d ANTIGEN
Version Model Number1403
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count1
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
GS100695684014032 [Primary]

FDA Product Code

GRLAntigens, All Groups, Salmonella Spp.

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 Date2016-04-21

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