K-ASSAY® RF Calibrator (Ver.2)

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® RF Calibrator (Ver.2) FDA UDI
Generic Name: Rheumatoid factor IVD, calibrator FDA UDI
Device Name: For the calibration of the K-ASSAY® RF (Ver.2) assay FDA UDI
Model / Reference: KAI-400C FDA UDI
Description: For the calibration of the K-ASSAY® RF (Ver.2) assay FDA UDI

Identifiers

Catalog Number: KAI-400C FDA UDI
Primary DI / UDI-DI: 00816426021532 FDA UDI
510(k) Number: K192727 FDA UDI
FDA Product Code: JIS FDA UDI
GMDN Term: Rheumatoid factor IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

Yes

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: Rheumatoid factor IVD, calibrator

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

Similar devices

Also classified as Rheumatoid factor IVD, calibrator.

Yumizen C1200 RF Cal — Horiba Abx · Class II
Alinity — Abbott · Class II
VITROS — Ortho-Clinical Diagnostics · Class II
ABX Pentra RF Cal — Horiba Abx · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class II
N Rheumatology Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
RF CAL — Randox Laboratories, Ltd. · Class II
N Rheumatology Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

Cleared under the same submission

K192727 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 II	Pending data

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

Manufacturer

Manufacturer: Kamiya Biomedical Company, Llc

Sources (1)

FDA UDI 03466028-7f58-4017-902d-83b68c566780 37 fields · synced Jun 1, 2026