Identity
- Trade Name
- Freelite® Lambda AMR Check Fluid SD FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
- Model / Reference
- BP539.SD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016810 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
A comprehensive and accurate medical device directory for the Freelite® Lambda AMR Check Fluid SD, including its features, regulatory compliance, and FAQs.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 3f9b134f-6000-44d4-a408-aa62b0926590 34 fields · synced Jun 24, 2026