FEBRILE POSITIVE CONTROL

GUDID 00695684016005

Febrile Positive Control is intended for use as a positive control for Febrile Antigen tests.

GERMAINE LABORATORIES, INC

Multiple febrile infection-associated bacteria antigen IVD, control
Primary Device ID00695684016005
NIH Device Record Key9a721103-333c-417f-a379-c3c17267201e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEBRILE POSITIVE CONTROL
Version Model Number1600
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
GS100695684016005 [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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