Identity
- Trade Name
- Optilite Hevylite® IgA Lambda Kit FDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK624.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700018494 FDA UDI
- 510(k) Number
- K160819 FDA UDI
- FDA Product Code
- OPY FDA UDI
- GMDN Term
- Total immunoglobulin A (IgA 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 A (IgA total) IVD, kit, nephelometry/turbidimetry
Optilite Hevylite® IgA Lambda Kit by The Binding Site Group — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry.
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- N Antisera to Human IgA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ADVIA® Chemistry IGA_2 Reagents — Siemens Healthcare Diagnostics · Class II
- Tinaquant IgA Gen2 — Roche Diagnostics Corp. · Class II
- Atellica CH IgA_2 — Siemens Healthcare Diagnostics · Class II
- N Antisera to Human IgA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Tinaquant IgA Gen2 — Roche Diagnostics Corp. · Class II
- Yumizen C1200 Immunoglobulin A — Horiba Abx · Class II
Cleared under the same submission
K160819 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI c992b3ba-c9c7-49f3-84d8-555dfe84995e 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026