SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests

Basic Information

• Brand Name: SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests
• Primary DI: 05032384029587
• Version / Model: TD0900A
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-11
• Public Version: 1
• Public Version Date: 2024-06-19
• Public Version Status: New
• Public Device Record Key: c0c0463e-772c-42c7-b840-350f4bbb2f01

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	866.3700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51680	Staphylococcus aureus multiple enterotoxin antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple enterotoxin antigens produced by Staphylococcus aureus bacteria in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384029587	GS1

Premarket Submissions

Submission Number	Supplement Number
K855233	000