STAPHYLASE TEST

GUDID 05032384013135

OXOID LIMITED

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Primary Device ID05032384013135
NIH Device Record Keyc490b3a1-ef3c-43bc-b7ef-33281a83e644
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAPHYLASE TEST
Version Model NumberDR0595A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105032384013135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHTStaphylococcus Aureus Somatic Antigens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-04

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