GUDID 05032384096442

OXOID LIMITED

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Primary Device ID05032384096442
NIH Device Record Keyb4e9218a-9f0a-4847-a74b-604af5d7c246
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDR0900A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384096442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYISystem,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies

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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