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Kova

FDA UDI

Class I (US FDA UDI)

by Kova International Inc

Identity

Trade Name
KOVA FDA UDI
Generic Name
General specimen microscopy slide IVD, single-use FDA UDI
Device Name
Super-Pac 1000 FDA UDI
Model / Reference
87154 FDA UDI
Description
Super-Pac 1000 FDA UDI

Identifiers

Catalog Number
87154 FDA UDI
Primary DI / UDI-DI
00850015517006 FDA UDI
FDA Product Code
KEW FDA UDI
NNK FDA UDI
GMDN Term
General specimen microscopy slide IVD, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen microscopy slide IVD, single-useCentrifuge tube IVDTest tube/reservoir cap

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

Similar devices

Also classified as Test tube/reservoir cap.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kova International Inc

Sources (1)

  • FDA UDI e2a8ae05-7f10-4530-bd30-d209d2dd685b 35 fields · synced Jun 6, 2026