Identity
- Trade Name
- β2-Microprotein (BMG) Test Kit (Latex Immunoturbidimetric) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, reagent FDA UDI
- Device Name
- β2-Microprotein (BMG) Test Kit (Latex Immunoturbidimetric) EUDAMED
- Model / Reference
- 校准品：1mL×1（91126） EUDAMEDCalibrator:1mL×1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674868019 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674868019 EUDAMED
- FDA Product Code
- JZG FDA UDI
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
- GMDN Term
- Beta-2-microglobulin IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
- Omlipo BMG Kit — Goldsite Diagnostics Inc. · IVD General
- Optilite® Beta-2 Microglobulin Urine Control Pack — The Binding Site Group Ltd. · Class B
- ReLIA — ReLIA Biotechnologies (Jiangsu), Inc. · IVD General
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
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI effcf97b-1c2d-4781-9174-93e871bfa869 32 fields · synced Jul 19, 2026
- EUDAMED c29c7dc8-50bd-4229-92ae-257756ce02ae 61 fields · synced Jul 19, 2026