Identity
- Trade Name
- Human Albumin Kit for use on SPAPLUS FDA UDI
- Generic Name
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK032.S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016087 FDA UDI
- GMDN Term
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- 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 Albumin Kit for use on SPAPLUS by The Binding Site Group — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 0c99f15f-d595-4fed-8958-6f55dcdbb846 35 fields · synced Jun 8, 2026