Identity
- Trade Name
- Human IgG4 SPA PLUS Bulk Kit FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK009.10S.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017978 FDA UDI
- 510(k) Number
- K072889 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- 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 IgG4 SPA PLUS Bulk Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry.
- Alinity — ABBOTT IRELAND · Class II
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- Alinity — Abbott · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Dimension® Flex® reagent cartridge IGG — Siemens Healthcare Diagnostics · Class II
- IgG — Randox Laboratories, Ltd. · Class II
- Optilite IgG3 — The Binding Site Group · Class II
- Optilite® IgG4 Kit (x10) — The Binding Site Group · Class II
Cleared under the same submission
K072889 also covers:
- Human IgG Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit — The Binding Site Group
- Human IgG1 SPA PLUS Bulk Kit — The Binding Site Group
- Human IgG2 SPA PLUS Bulk Kit — The Binding Site Group
- Human IgG3 SPA PLUS Bulk Kit — The Binding Site Group
- Optilite IgG Kit — The Binding Site Group
- Optilite IgG1 Kit — The Binding Site Group
- Optilite IgG2 Kit — The Binding Site Group
- Optilite® IgG Kit (x10) — The Binding Site Group
- Optilite® IgG1 Kit (x10) — The Binding Site Group
- Optilite® IgG2 Kit (x10) — The Binding Site Group
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI b471ba0f-b826-46f3-8b31-bfcf33aba52e 35 fields · synced Jun 8, 2026