Kova

FDA UDI

Class I (US FDA UDI)

by Kova International Inc

Identity

Trade Name: KOVA FDA UDI
Generic Name: Urine sediment IVD, control FDA UDI
Device Name: KOVA-TROL I HIGH ABNORMAL WO U/B FDA UDI
Model / Reference: 87325E FDA UDI
Description: KOVA-TROL I HIGH ABNORMAL WO U/B FDA UDI

Identifiers

Catalog Number: 87325E FDA UDI
Primary DI / UDI-DI: 00855617006620 FDA UDI
510(k) Number: K843565 FDA UDI
FDA Product Code: JJW FDA UDI
GMDN Term: Urine sediment IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine sediment IVD, control

Kova by Kova International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine sediment IVD, control.

McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
Dipper POCT Level 1&2 Set 62x1.5mL — QUANTIMETRIX CORP. · Class I
QuanTscopics Control Level 2 Set 4x120mL — QUANTIMETRIX CORP. · Class I
Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL — QUANTIMETRIX CORP. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
Chromascopics Control Level 1&2 Set 4x120mL (International) — QUANTIMETRIX CORP. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
UA-Cellular for UF — Streck · Class II

Cleared under the same submission

K843565 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kova International Inc

Sources (1)

FDA UDI 8d0ea1d4-5c27-44e0-8a9e-180289d1966e 37 fields · synced May 30, 2026