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K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control

FDA UDI

Class I (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma 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
K283C-4M 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
K283C-4M FDA UDI
Primary DI / UDI-DI
00816426021327 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

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

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: Beta-2-microglobulin IVD, control

K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control by Kamiya Biomedical Company, Llc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

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

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 eb50d58c-dbbc-4a0c-9bdb-f167cd855e91 36 fields · synced May 30, 2026