Identity
- Trade Name
- K-ASSAY® Beta-2 Microglobulin Reagent FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay. FDA UDI
- Model / Reference
- KAI-280 FDA UDI
- Description
- For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay. FDA UDI
Identifiers
- Catalog Number
- KAI-280 FDA UDI
- Primary DI / UDI-DI
- 00816426021280 FDA UDI
- FDA Product Code
- JZG FDA UDI
- GMDN Term
- Beta-2-microglobulin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5630 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, reagent
K-ASSAY® Beta-2 Microglobulin Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
- Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) — WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
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 |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI 643b8e57-9a0d-4d22-a920-90d437449fdb 36 fields · synced May 30, 2026