Identity
- Trade Name
- Human Prealbumin Kit for use on SPAPLUS FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK066.S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016100 FDA UDI
- FDA Product Code
- JZJ FDA UDI
- GMDN Term
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5060 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Human Prealbumin Kit for use on SPAPLUS by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a2bfc9bf-2487-4ceb-89e3-431675e6e17e 35 fields · synced Jun 1, 2026