Oxoid Streptococcal Grouping Kit

GUDID 05032384013036

OXOID LIMITED

Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination
Primary Device ID05032384013036
NIH Device Record Keybea5e372-df15-4165-849e-e7a3ecd4d50d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxoid Streptococcal Grouping Kit
Version Model NumberDR0585A
Company DUNS365355452
Company NameOXOID LIMITED
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 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
GS105032384013036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GTZAntisera, All Groups, Streptococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-26
Device Publish Date2024-06-18

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.