Identity
- Trade Name
- Human IgA2 Kit for use on SPAPLUS FDA UDI
- Generic Name
- Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK088.S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700012324 FDA UDI
- 510(k) Number
- K100588 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
Human IgA2 Kit for use on SPAPLUS by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100588 also covers:
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 512e6756-6876-4316-95b3-38ca46291c47 36 fields · synced Jun 8, 2026