GUDID 05032384068326

OXOID LIMITED

Azithromycin susceptibility testing disc IVD
Primary Device ID05032384068326
NIH Device Record Key351f5984-6619-4f72-8bb2-65dde7936464
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCT0906B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384068326 [Primary]
GS105032384502226 [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

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