Kovac's Reagent (100ml)

Basic Information

• Brand Name: Kovac's Reagent (100ml)
• Primary DI: 05060472460004
• Version / Model: PL.375
• Catalog Number: PL.375
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-24
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: 798209b4-5c7e-48be-9ee3-b0137c73801e

Device Description

Pro-Lab’s Spot Indole Reagent is to be used in the qualitative method to determine the ability of an organism to split indole from the tryptophan molecule.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43720	Indole/Kovac's microbial reagent IVD	A substance or reactant, sometimes referred to as indole reagent or Kovac's reagent, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060472460004	GS1