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K-ASSAY® RF Reagent (Ver.2)

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® RF Reagent (Ver.2) FDA UDI
Generic Name
Rheumatoid factor IVD, reagent FDA UDI
Device Name
For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay. FDA UDI
Model / Reference
KAI-230 FDA UDI
Description
For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number
KAI-230 FDA UDI
Primary DI / UDI-DI
00816426021457 FDA UDI
510(k) Number
K192727 FDA UDI
FDA Product Code
DHR FDA UDI
GMDN Term
Rheumatoid factor IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rheumatoid factor IVD, reagent

K-ASSAY® RF Reagent (Ver.2) by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K192727 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kamiya Biomedical Company, Llc

Sources (1)

  • FDA UDI 8770c31c-f16f-4ccb-825a-8bd799511854 37 fields · synced Jun 8, 2026