Uric Reagent Kit

FDA UDI

Class I (US FDA UDI)

by Medica Corp.

Identity

Trade Name: Uric Reagent Kit FDA UDI
Generic Name: Uric acid IVD, kit, spectrophotometry FDA UDI
Device Name: Uric Acid Reagent Kit for use with EasyRA Analyzers FDA UDI
Model / Reference: 10208-4 FDA UDI
Description: Uric Acid Reagent Kit for use with EasyRA Analyzers FDA UDI

Identifiers

Catalog Number: 10208-4 FDA UDI
Primary DI / UDI-DI: 00386100002046 FDA UDI
510(k) Number: K080823 FDA UDI
FDA Product Code: KNK FDA UDI
GMDN Term: Uric acid IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1775 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Uric acid IVD, kit, spectrophotometry

Uric Reagent Kit by Medica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K080823 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: Medica Corp.

Sources (1)

FDA UDI f5a790d9-468c-492d-8325-b14fc21c2ee5 37 fields · synced May 30, 2026