STREPTOCOCCUS SELECTIVE SUPPL.1X10 VIALS

GUDID 05032384011988

OXOID LIMITED

Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD
Primary Device ID05032384011988
NIH Device Record Key778cf66b-1899-46bc-8508-2025c782d3a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTREPTOCOCCUS SELECTIVE SUPPL.1X10 VIALS
Version Model NumberSR0126E
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
GS105032384011988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSKSupplement, Culture Media

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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05032384029587 - SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests2024-06-19
05032384029594 - TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests2024-06-19
05032384001071 - PEPTONE WATER2024-06-12
05032384003976 - MAXIMUM RECOVERY DILUENT 2024-06-12
05032384000975 - NUTRIENT BROTH2024-06-11

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