Spot Indole Reagent (10ml)

Basic Information

• Brand Name: Spot Indole Reagent (10ml)
• Primary DI: 05060472466785
• Version / Model: PL.391-10
• Catalog Number: PL.391-10
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: de2669cc-ad64-4a63-b76a-885ae4e0f73b

Device Description

The active ingredient in our Spot Indole Reagent is p-dimethylaminocinnamaldehyde (PACA). The reagent will turn blue in the presence of Indole produced during Tryptophan degradation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
JSF	Culture Media, Single Biochemical Test	Microbiology	866.2320	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	05060472466785	GS1