Identity
- Trade Name
- Hevylite IgM Kappa Kit for Siemens BNII FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK625.T.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016995 FDA UDI
- 510(k) Number
- K113823 FDA UDI
- FDA Product Code
- CFN FDA UDIPDE 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
Hevylite IgM Kappa Kit for Siemens BNII by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — 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
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- 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
K113823 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 8856cfdf-eed7-4b18-8f0b-780c477a3d29 35 fields · synced May 31, 2026