API®50 CH

Basic Information

• Brand Name: API®50 CH
• Primary DI: 03573026588694
• Version / Model: API®50 CH
• 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: 2faa3697-1d3f-4130-8f51-f8bff275cde6

Device Description

API 50 CH combines 50 biochemical tests for ID of Lactobacillus and related genera as well as Bacillus and related genera, Enterobacteriaceae and Vibrionaceae.

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
JSC	CULTURE MEDIA, GENERAL NUTRIENT BROTH	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61331	Multiple bacteria species culture isolate identification control IVD, kit	A collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been 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	03573026087401	GS1		10	In Commercial Distribution
Primary	03573026588694	GS1

Storage Conditions

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