Identity
- Trade Name
- Optilite® Beta-2 Microglobulin Kit FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK043.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017619 FDA UDI
- 510(k) Number
- K083289 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
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
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, nephelometry/turbidimetry
Optilite® Beta-2 Microglobulin Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry.
- β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
- Tinaquant 2Microglobulin — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Tinaquant ß2Microglobulin — Roche Diagnostics Corp. · Class II
- N Latex ß2-Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Atellica CH B2M — Siemens Healthcare Diagnostics · Class II
- Dimension Vista® ß2-Microglobulin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Beckman Coulter Beta-2-Microglobulin Kit — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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
- The Binding Site Group
Sources (1)
- FDA UDI 0320a43d-3b43-41fe-8af8-c5a1d3629400 35 fields · synced May 30, 2026