IMAGEN RESPIRATORY SCREEN POS CON SLIDE

GUDID 05032384503070

OXOID LIMITED

Multiple-genus respiratory virus antigen IVD, control
Primary Device ID05032384503070
NIH Device Record Keyf6c1f3ce-2f1b-476d-b0a8-c0bb4887d7b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGEN RESPIRATORY SCREEN POS CON SLIDE
Version Model NumberS612130-2
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384503070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GNWAntisera, Cf, 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 Date2024-07-11
Device Publish Date2024-07-03

Devices Manufactured by OXOID LIMITED

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
05032384526123 - Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test Discs2024-10-09
05032384002092 - Desoxycholate Citrate Agar (Hynes)2024-08-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.