KOVA

Basic Information

• Brand Name: KOVA
• Primary DI: 00855617006439
• Version / Model: 37036
• Catalog Number: 37036
• Company Name: KOVA INTERNATIONAL, INC.
• Labeler DUNS: 078780990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-31
• Public Version: 1
• Public Version Date: 2020-08-10
• Public Version Status: New
• Public Device Record Key: 03f2e73d-c3a0-4e86-9636-fc6e86f51ebf

Device Description

1x120mL vial abnormal and 1x20mL vial normal

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: No
• 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
JJW	Urinalysis Controls (Assayed And Unassayed)	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	00855617006439	GS1

Customer Contacts

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

Storage Conditions

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