InTray® SAB+PVG

Basic Information

• Brand Name: InTray® SAB+PVG
• Primary DI: B088212730010
• Version / Model: 2127
• Company Name: BIO-MED DIAGNOSTICS, INC.
• Labeler DUNS: 605213545
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-05
• Public Version: 1
• Public Version Date: 2023-10-13
• Public Version Status: New
• Public Device Record Key: 51b0a364-0c42-40b7-81b3-d72dd2053fb5

Device Description

InTray SAB+PVG is for growth and observation of fungi, yeasts and dermatophytes. Inhibition is enhanced with the introduction of Polymyxin B, Vancomycin and Gentamicin.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JSJ	Culture Media, Selective And Non-Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33358	Multiple dermatophyte species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of dermatophyte or other fungi isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B088212730010	HIBCC