Oxoid Reaction Cards

GUDID 05032384012954

OXOID LIMITED

Microbial-isolate agglutination assay reaction card IVD
Primary Device ID05032384012954
NIH Device Record Key5c04ddbc-b2fb-4604-a32e-b05211bcc90f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxoid Reaction Cards
Version Model NumberDR0500G
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 Usetrue
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
GS105032384012954 [Primary]

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

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