APIWEB™

Basic Information

• Brand Name: APIWEB™
• Primary DI: 03573026133542
• Version / Model: 1.4
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-01
• Public Version: 1
• Public Version Date: 2022-04-11
• Public Version Status: New
• Public Device Record Key: 2a41adc5-92c1-48d8-ab07-18108d8517fd

Device Description

APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical device data system	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61487	Human infectome analysis interpretive software IVD	An in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026133542	GS1