Identity
- Trade Name
- Optilite Alpha-2-macroglobulin Kit FDA UDI
- Generic Name
- Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK039.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017480 FDA UDI
- 510(k) Number
- K140664 FDA UDI
- FDA Product Code
- DEB FDA UDI
- GMDN Term
- Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5620 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: Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry
Optilite Alpha-2-macroglobulin Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry.
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 0f84bf85-3e91-483b-8f68-dea33484a61a 35 fields · synced Jun 8, 2026