API® JAMES

Basic Information

• Brand Name: API® JAMES
• Primary DI: 03573026099893
• Version / Model: 70542
• 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: ac294ece-8c3c-4000-9504-6311447cf986

Device Description

JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E

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
50416	Multiple Enterobacteriaceae species culture isolate identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, 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
Primary	03573026099893	GS1

Storage Conditions

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