API® ID-ASE

Basic Information

• Brand Name: API® ID-ASE
• Primary DI: 03573026584139
• Version / Model: API® ID-ASE
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 1
• Public Version Date: 2019-07-29
• Public Version Status: New
• Public Device Record Key: 8b661a60-e65a-4aa9-90df-763ced591d95

Device Description

Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems.

Device Characteristics

• Single Use: No
• 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
42736	Catalase production microbial reagent IVD	A substance or reactant, sometimes referred to as hydrogen peroxide reagent, intended to be used in microbial testing to detect the enzyme catalase produced by a microorganism isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026092009	GS1		2	In Commercial Distribution
Primary	03573026584139	GS1

Storage Conditions

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