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Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™
FDA UDIEUDAMEDIdentity
- Trade Name
- Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™ FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
- Model / Reference
- NQ018.IM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700018715 FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
Classification
- 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, control
Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™ by The Binding Site Group — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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- N FLC Control SL1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N FLC CONTROL SL2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 004202a5-35a0-4218-8aeb-a59ac2118fdd 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026