SIGNAL BLOOD CULTURE SYSTEM 1 X 20

GUDID 05032384013623

OXOID LIMITED

Blood culture broth kit IVD
Primary Device ID05032384013623
NIH Device Record Key1ff10dad-0613-4232-9f37-59c6e728442a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIGNAL BLOOD CULTURE SYSTEM 1 X 20
Version Model NumberBC0100M
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
GS105032384013623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSGCulture Media, Non-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 Date2022-12-12
Device Publish Date2022-12-04

Devices Manufactured by OXOID LIMITED

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05032384519828 - ProSpecT™ Wash Buffer2024-07-15
05032384503032 - IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE2024-07-11

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