Freelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Freelite® Human Kappa Free Kit (for use on the Siemens BN™II) EUDAMEDFreelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit FDA UDIFreelite® Human Kappa Free Kit for use on the Siemens BN™II FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Freelite® Human Kappa Free Kit for use on the Siemens BN™II EUDAMED
- Model / Reference
- LK016.T EUDAMEDFDA UDILK016.10T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700006378 EUDAMEDFDA UDI05051700006279 FDA UDI
- Basic UDI-DI
- B-05051700006378 EUDAMED
- FDA Product Code
- DFH FDA UDI
- EMDN Code
- W0102010109 KAPPA AND LAMBDA CHAIN EUDAMED
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Freelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit by The Binding Site Group — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (3)
- FDA UDI b2677ffd-0cc1-468e-ac15-08c4b4241266 34 fields · synced Oct 6, 2026
- FDA UDI 3cc0b9d2-b551-4d4f-b47e-ab0faf387393 34 fields · synced May 30, 2026
- EUDAMED 64243955-448f-4e6c-b28c-7bbaf2292b6a 61 fields · synced Jul 16, 2026