IMAGEN Influenza Virus A and B

GUDID 05032384502981

OXOID LIMITED

Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Primary Device ID05032384502981
NIH Device Record Key0780d4a0-e342-4426-a89d-31eafcf33016
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGEN Influenza Virus A and B
Version Model NumberK610511-2
Company DUNS365355452
Company NameOXOID LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com
Phone+441256694238
Emailoxoid.techsupport@thermofisher.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384502981 [Primary]

FDA Product Code

GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-07
Device Publish Date2024-12-30

Devices Manufactured by OXOID LIMITED

05032384502974 - IMAGEN Parainfluenza Virus Types 1, 2 and 32025-01-07
05032384502981 - IMAGEN Influenza Virus A and B2025-01-07
05032384502981 - IMAGEN Influenza Virus A and B2025-01-07
05032384082919 - ORSAB SELECTIVE SUPPLEMENT2024-11-06
05032384083237 - OXACILLIN RES. SCREENING AGAR BASE2024-11-06
05032384128006 - Microbact Staph 12S2024-11-05
05032384128013 - Microbact Staph Fast Blue Reagent2024-11-05
05032384580231 - Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs2024-11-05
05032384579945 - Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di2024-11-05

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.