Identity
- Trade Name
- Human IgG2 SPA PLUS Bulk Kit FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK007.10S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016384 FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Commercial Distribution
- 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
Category: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Human IgG2 SPA PLUS Bulk Kit by The Binding Site Group — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry.
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- IgG — Randox Laboratories, Ltd. · Class II
- Human IgG4 SPA PLUS Bulk Kit — The Binding Site Group · Class II
- Optilite IgG3 — The Binding Site Group · Class II
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 cf68c7d2-651e-4b13-ae33-c228be53a735 34 fields · synced May 30, 2026