Identity
- Trade Name
- N Antisera to Human IgM FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of IgM in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446303 FDA UDI
- Description
- Quantitative determination of IgM in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OSAT19 FDA UDI
- Primary DI / UDI-DI
- 00842768009846 FDA UDI
- 510(k) Number
- K042735 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 Antisera to Human IgM by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry.
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- 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
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 e4d04d06-e739-42c7-beee-014ae30bdf90 37 fields · synced Jun 8, 2026