CLOSTRIDIUM DIFFICILE

GUDID 05032384003648

OXOID LIMITED

Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD
Primary Device ID05032384003648
NIH Device Record Keyef0de888-2f53-4ade-8377-044d54e08316
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLOSTRIDIUM DIFFICILE
Version Model NumberCM0601B
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
GS105032384003648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSJCulture Media, Selective And Non-Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

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05032384503070 - IMAGEN RESPIRATORY SCREEN POS CON SLIDE2024-07-11
05032384519583 - ProSpecT Campylobacter Microplate Assay 96 Tests2024-06-28
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05032384013036 - Oxoid Streptococcal Grouping Kit2024-06-26

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