Identity
- Trade Name
- N Latex IgM FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems FDA UDI
- Model / Reference
- 10873688 FDA UDI
- Description
- Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems FDA UDI
Identifiers
- Catalog Number
- OQAC15 FDA UDI
- Primary DI / UDI-DI
- 00630414285023 FDA UDI
- 510(k) Number
- K032014 FDA UDI
- FDA Product Code
- CFN 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
N Latex IgM by Siemens Healthcare Diagnostics Products Ltd — 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.
- Optilite IgM Kit — The Binding Site Group · Class II
- Tinaquant IgM Gen2 — Roche Diagnostics Corp. · Class II
- Hevylite IgM Kappa Kit for Siemens BNII — The Binding Site Group · Class II
- Tinaquant IgM Gen2 — Roche Diagnostics Corp. · Class II
- ADVIA® Chemistry IGM_2 Reagents — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
- Alinity — ABBOTT IRELAND · Class II
- Optilite Hevylite® IgM Lambda Kit — The Binding Site Group · Class II
Cleared under the same submission
K032014 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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 43d63b13-be99-4020-8a0f-606760439877 37 fields · synced May 29, 2026