GUDID 05032384006694

OXOID LIMITED

Ofloxacin susceptibility testing disc IVD
Primary Device ID05032384006694
NIH Device Record Key81aee416-00f7-4ab7-a5e2-223e5e3dc7a4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCT0446B
Company DUNS365355452
Company NameOXOID LIMITED
Device Count5
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
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
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
GS105032384006694 [Primary]
GS105032384502318 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JTNSusceptibility Test Discs, Antimicrobial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by OXOID LIMITED

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
05032384011414 - Campylobacter Selective Supplement (Skirrow)2024-08-21
05032384028467 - Oxoid™ (8 Places, 90 mm skirt) Antimicrobial Susceptibility Disc Dispenser2024-08-21

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