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K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, calibrator FDA UDI
- Device Name
- For the calibration of the K-ASSAY® Beta-2 Microglobulin assay. FDA UDI
- Model / Reference
- KAI-281C FDA UDI
- Description
- For the calibration of the K-ASSAY® Beta-2 Microglobulin assay. FDA UDI
Identifiers
- Catalog Number
- KAI-281C FDA UDI
- Primary DI / UDI-DI
- 00816426021297 FDA UDI
- FDA Product Code
- JZG FDA UDI
- GMDN Term
- Beta-2-microglobulin IVD, calibrator 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, calibrator
K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Beta-2-microglobulin IVD, calibrator.
- Atellica CH B2M Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class II
- BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) — Randox Laboratories, Ltd. · Class II
- K-ASSAY® Beta-2 Microglobulin Urine Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
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 6ac77fd3-62ee-4c11-808d-7043760c2d7f 36 fields · synced Jun 6, 2026