ProSpecT Campylobacter Microplate Assay 96 Tests

GUDID 05032384519583

OXOID LIMITED

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05032384519583
NIH Device Record Keye8dd6b42-adb7-43db-b370-e5cc45e4f184
Commercial Distribution StatusIn Commercial Distribution
Brand NameProSpecT Campylobacter Microplate Assay 96 Tests
Version Model NumberR2476096
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
GS105032384519583 [Primary]

FDA Product Code

LQPCampylobacter Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

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