Identity
- Trade Name
- Optilite Freelite Mx Lambda Free Kit FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK018.M.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700019873 FDA UDI
- 510(k) Number
- K173732 FDA UDI
- FDA Product Code
- DEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 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: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Optilite Freelite Mx Lambda Free Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry.
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- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Dimension Vista® Flex® reagent cartridge KAPPA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N LATEX FLC KAPPA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Antiserum to Human-Ig/L-chain, L-type — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K173732 also covers:
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 d3d0ff07-a10a-4719-9dbd-9ce53388320c 35 fields · synced Jun 6, 2026