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Sheep Anti-Human Lambda Free Light Chains Immunofixation Grade
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sheep Anti-Human Lambda Free Light Chains Immunofixation Grade FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
- Model / Reference
- PX018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700010177 FDA UDI
- FDA Product Code
- DEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 FDA UDI
- Commercial Distribution
- Not 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
Sheep Anti-Human Lambda Free Light Chains Immunofixation Grade by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID
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
- The Binding Site Group
Sources (1)
- FDA UDI a4a9aceb-5927-4bf5-8d69-682bca9eee63 35 fields · synced May 30, 2026