Identity
- Trade Name
- Lambda light chains FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, reagent FDA UDI
- Device Name
- The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems. FDA UDI
- Model / Reference
- A26849 FDA UDI
- Description
- The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems. FDA UDI
Identifiers
- Catalog Number
- A26849 FDA UDI
- Primary DI / UDI-DI
- 08058056681263 FDA UDI
- 510(k) Number
- K083601 FDA UDI
- FDA Product Code
- DEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, reagent 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
Dimensions & Sizes
- Size
- Total Volume — 120 Milliliter FDA UDI
Category: Kappa/lambda light chain immunoglobulin IVD, reagent
Lambda light chains by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Kappa/lambda light chain immunoglobulin IVD, reagent.
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- ANTI-LAMBDA LIGHT CHAIN — Biogenex Laboratories, Inc. · Class I
- N FLC Supplementary Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Anti-Human Total Lambda - Particle - ASR pack — The Binding Site Group · Class I
- ANTI-KAPPA LIGHT CHAIN — Biogenex Laboratories, Inc. · Class I
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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 526f85a0-e79a-415a-9e23-2fed082d55ee 38 fields · synced Jun 6, 2026