rapid ID 32 STREP

Basic Information

• Brand Name: rapid ID 32 STREP
• Primary DI: 03573026588625
• Version / Model: rapid ID 32 STREP
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-10
• Public Version: 1
• Public Version Date: 2020-04-20
• Public Version Status: New
• Public Device Record Key: ab90cb75-9745-4cb3-9329-c42681f9fb63

Device Description

rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JTO	DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51701	Multiple Streptococcus bacterial 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 Streptococcus bacteria, or other similar gram positive, catalase negative cocci isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026066536	GS1		25	In Commercial Distribution
Primary	03573026588625	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius