Identity
- Trade Name
- Optilite Hevylite® IgM Kappa Kit FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK625.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700018357 FDA UDI
- 510(k) Number
- K152389 FDA UDI
- FDA Product Code
- PDE FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM 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 M (IgM total) IVD, kit, nephelometry/turbidimetry
Optilite Hevylite® IgM 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 M (IgM total) IVD, kit, nephelometry/turbidimetry.
- Tinaquant IgM Gen2 — Roche Diagnostics Corp. · Class II
- Tinaquant IgM Gen2 — Roche Diagnostics Corp. · Class II
- ADVIA® Chemistry IGM_2 Reagents — Siemens Healthcare Diagnostics · Class II
- N Latex IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Alinity — Abbott · Class II
- Alinity — ABBOTT IRELAND · Class II
- Yumizen C1200 Immunoglobulin M — Horiba Abx · Class II
- DImension Vista® Immunoglobulin M Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K152389 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 0d45d4a9-6ff4-4e72-b474-d3507d8d5c91 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026