SALMONELLA O POLY POSITIVE CONTROL

GUDID 00695684016111

Salmonella O Poly Positive controls are intended for use as positive controls for salmonella somatic antigens.

GERMAINE LABORATORIES, INC

Salmonella paratyphi antigen IVD, control Salmonella paratyphi antigen IVD, control
Primary Device ID00695684016111
NIH Device Record Keyef3ee3d2-e815-4a9c-8307-d0b4a2fba4b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALMONELLA O POLY POSITIVE CONTROL
Version Model Number1611
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
GS100695684016111 [Primary]

FDA Product Code

GSNAntiserum, Positive And Negative Febrile Antigen Control Serum

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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