STREPTOCOCCUS SELECTIVE SUPPL.1X10 VIALS

Basic Information

• Brand Name: STREPTOCOCCUS SELECTIVE SUPPL.1X10 VIALS
• Primary DI: 05032384011988
• Version / Model: SR0126E
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 778cf66b-1899-46bc-8508-2025c782d3a3

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
JSK	Supplement, Culture Media	Microbiology	866.2450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58556	Culture medium antimicrobial supplement IVD	A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384011988	GS1

Premarket Submissions

Submission Number	Supplement Number
K800260	000