Identity
- Trade Name
- Optilite IgD Kit FDA UDI
- Generic Name
- Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK013.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017572 FDA UDI
- 510(k) Number
- K092450 FDA UDI
- FDA Product Code
- CZJ FDA UDI
- GMDN Term
- Total immunoglobulin D (IgD total) 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: Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
Optilite IgD Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry.
- IgD AMR Fluid — The Binding Site Group · Class I
- Human IgD Kit for use on SPAPLUS — The Binding Site Group · Class II
Cleared under the same submission
K092450 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 38286736-cf4f-4bec-92fa-e7253b225edf 35 fields · synced Jun 8, 2026