Identity
- Trade Name
- FLC Lambda FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 5103 FDA UDI
Identifiers
- Catalog Number
- 5103 FDA UDI
- Primary DI / UDI-DI
- 03607360051030 FDA UDI
- 510(k) Number
- K210623 FDA UDI
- FDA Product Code
- DEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)
FLC Lambda by Sebia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA).
- FLC Kappa — Sebia, Inc. · Class II
Cleared under the same submission
K210623 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sebia, Inc.
Sources (1)
- FDA UDI 324d38c0-4c80-4eca-a6df-0ec519b4fd05 35 fields · synced Jun 1, 2026