Identity
- Trade Name
- N FLC STANDARD SL FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, calibrator FDA UDI
- Device Name
- Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on BN Systems. FDA UDI
- Model / Reference
- 10873662 FDA UDI
- Description
- Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on BN Systems. FDA UDI
Identifiers
- Catalog Number
- OPJD05 FDA UDI
- Primary DI / UDI-DI
- 00630414237497 FDA UDI
- 510(k) Number
- K171742 FDA UDI
- FDA Product Code
- DFH FDA UDIDEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, calibrator 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
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: Kappa/lambda light chain immunoglobulin IVD, calibrator
N Flc Standard Sl by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kappa/lambda light chain immunoglobulin IVD, calibrator.
Cleared under the same submission
K171742 also covers:
- N FLC CONTROL SL1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC CONTROL SL2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC Control SL1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC Control SL2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC SUPPLEMENTARY REAGENT — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N FLC Supplementary Reagent — 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 d6a84d9b-b6c4-4d4f-b4c8-9037a0018640 37 fields · synced Jun 6, 2026