K-ASSAY® Beta-2 Microglobulin Urine Control

FDA UDI

Class I (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® Beta-2 Microglobulin Urine Control FDA UDI
Generic Name: Beta-2-microglobulin IVD, control FDA UDI
Device Name: For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin. FDA UDI
Model / Reference: K284C-2M FDA UDI
Description: For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin. FDA UDI

Identifiers

Catalog Number: K284C-2M FDA UDI
Primary DI / UDI-DI: 00816426021334 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Beta-2-microglobulin 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Beta-2-microglobulin IVD, control

K-ASSAY® Beta-2 Microglobulin Urine Control by Kamiya Biomedical Company, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-2-microglobulin IVD, control.

IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
IMMULITE Systems Beta-2 Microglobulin CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I

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: Kamiya Biomedical Company, Llc

Sources (1)

FDA UDI d93531ff-9505-476e-8b08-891afce191d4 36 fields · synced May 30, 2026