ID indole TDA

Basic Information

• Brand Name: ID indole TDA
• Primary DI: 03573026092443
• Version / Model: ID indole TDA
• 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: e2d7e7bf-4aa0-4fce-bdb2-6f2a9a68bc00

Device Description

Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics

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
JSS	KIT, IDENTIFICATION, ENTEROBACTERIACEAE	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43714	Tryptophan utilization/spot indole microbial reagent IVD	A reactant intended to be used in microbial testing to detect tryptophan metabolites (e.g., indole, indole-pyruvic acid) produced via enzymatic breakdown 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
Primary	03573026092443	GS1

Storage Conditions

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