N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027458
• Version / Model: Z67
• Catalog Number: Z67
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-16
• Public Version: 1
• Public Version Date: 2020-06-24
• Public Version Status: New
• Public Device Record Key: 6ac71275-5751-49c2-84b7-8dcd9dea3a02

Device Description

Indole, Kovac's Reagent, for tube test, 15ml P-dimethylaminobenzaldehyde, to test indole production in indole broth or for biochemical strip/cupule methods. Positive indole reactions with Kovac's will turn pink to red. Does not require a xylene or chloroform extraction as with Ehrlich's Reagent. Kovac's Reagent is not for rapid spot indole on filter paper. For the rapid spot test, see Cat. no. K65, which is DMACA (cinnamaldehyde).

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	00819398027458	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius