KOVA-Trol III Normal with hCG

Basic Information

• Brand Name: KOVA-Trol III Normal with hCG
• Primary DI: 00850075957378
• Version / Model: 87327
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 106267123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-17
• Public Version: 1
• Public Version Date: 2026-04-27
• Public Version Status: New
• Public Device Record Key: b702b61d-3bb9-410d-a80f-5a552305e534

Device Description

KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control for qualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopic sediment analyses. For professional laboratory use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42065	Urine sediment IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850075957378	GS1

Storage Conditions

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