Identity
- Trade Name
- Lipoprotein (a) Kit for use on SPAPLUS FDA UDI
- Generic Name
- Lipoprotein A IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK098.S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016841 FDA UDI
- FDA Product Code
- JIS FDA UDIJJS FDA UDIDFC FDA UDI
- GMDN Term
- Lipoprotein A IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1660 FDA UDI866.5600 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
Lipoprotein (a) Kit for use on SPAPLUS by The Binding Site Group — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 1bea18d5-461a-4080-9b0c-979348492c18 35 fields · synced May 30, 2026