SALMONELLA H POLY POSITIVE CONTROL

GUDID 00695684016067

Febrile Controls are intended for use as positive & negative controls for these tests.

GERMAINE LABORATORIES, INC

Salmonella paratyphi antigen IVD, control Salmonella paratyphi antigen IVD, control
Primary Device ID00695684016067
NIH Device Record Key5e6792c3-2d65-4b90-bf1a-479cde690f3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALMONELLA H POLY POSITIVE CONTROL
Version Model Number1606
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
GS100695684016067 [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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