SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests

GUDID 05032384029587

OXOID LIMITED

Staphylococcus aureus multiple enterotoxin antigen IVD, kit, agglutination
Primary Device ID05032384029587
NIH Device Record Keyc0c0463e-772c-42c7-b840-350f4bbb2f01
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests
Version Model NumberTD0900A
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
GS105032384029587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-19
Device Publish Date2024-06-11

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