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 4X15ML FDA UDI
Model / Reference: 87329 FDA UDI
Description: KOVA-TROL I 4X15ML FDA UDI

Identifiers

Catalog Number: 87329 FDA UDI
Primary DI / UDI-DI: 00855617006651 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

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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

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Manufacturer

Manufacturer: Kova International Inc

Sources (1)

FDA UDI 203b7dbd-1918-4118-adff-4810a7ba2117 37 fields · synced May 30, 2026