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IMMULITE® / IMMULITE® 1000 Systems BMG Beta-2 Microglobulim
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE® / IMMULITE® 1000 Systems BMG Beta-2 Microglobulim FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- b2 Microglobulin - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10380950 FDA UDI
- Description
- b2 Microglobulin - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKBM1 FDA UDI
- Primary DI / UDI-DI
- 00630414963648 FDA UDI
- 510(k) Number
- K931702 FDA UDI
- FDA Product Code
- JZG FDA UDI
- GMDN Term
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay 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
Yes
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
No
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, kit, chemiluminescent immunoassay
IMMULITE® / IMMULITE® 1000 Systems BMG Beta-2 Microglobulim by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
K931702 also covers:
- IMMULITE/IMMULITE 1000 Systems Beta-2-Microglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE/IMMULITE 1000 Systems Beta-2-Microglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems BMG Beta-2 Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 7a463a5f-e488-4da0-8e46-84e637a138f5 37 fields · synced May 30, 2026