API® ZYM B

Basic Information

• Brand Name: API® ZYM B
• Primary DI: 03573026141998
• Version / Model: 70493
• 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: 34eb61be-0d72-4729-afc1-146d63fdf580

Device Description

ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
51656	Multiple Staphylococcus 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 Staphylococcus bacteria or other similar gram positive, catalase positive 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
Primary	03573026141998	GS1

Storage Conditions

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