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β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- None FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970291985215 FDA UDI
- FDA Product Code
- JZG FDA UDI
- GMDN Term
- Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) by Medicalsystem Biotechnology Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID…
Similar devices
Also classified as Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry.
- Tinaquant 2Microglobulin — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Tinaquant ß2Microglobulin — Roche Diagnostics Corp. · Class II
- B2M AMR Fluid — The Binding Site Group · Class I
- N Latex ß2-Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Human Beta-2 Microglobulin Urine Kit for use on the SPAPLUS — The Binding Site Group · Class II
- Atellica CH B2M — Siemens Healthcare Diagnostics · Class II
- Dimension Vista® ß2-Microglobulin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medicalsystem Biotechnology Co., Ltd.
Sources (2)
- FDA UDI 46010ce7-6dd8-4238-bbe6-292e9ab4cbf4 32 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026