Identity
- Trade Name
- Optilite Hevylite IgG Kappa Kit FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK621.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700020114 FDA UDI
- 510(k) Number
- K172613 FDA UDI
- FDA Product Code
- PCN FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG 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 G (IgG total) IVD, kit, nephelometry/turbidimetry
Optilite Hevylite IgG Kappa 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 G (IgG total) IVD, kit, nephelometry/turbidimetry.
- ADVIA® Chemistry IGG_2 Reagents — Siemens Healthcare Diagnostics · Class II
- DImension Vista® Immunoglobulin G Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Yumizen C1200 Immunoglobulin G — Horiba Abx · Class II
- Tinaquant IgG Gen2 — Roche Diagnostics Corp. · Class II
- IGG Immunoglobulin G Turbidimetric) — Roche Diagnostics Corp. · Class II
- Atellica CH IgG_2 — Siemens Healthcare Diagnostics · Class II
- N Antisera to Human IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Tinaquant IgG Gen2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K172613 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 42cdd9d1-2e8e-4628-83ee-99524ea776ec 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026