Identity
- Trade Name
- N Antiserum to Human Hemopexin FDA UDI
- Generic Name
- Haemopexin IVD, reagent FDA UDI
- Device Name
- Quantitative determination of hemopexin in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446493 FDA UDI
- Description
- Quantitative determination of hemopexin in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OUVN09 FDA UDI
- Primary DI / UDI-DI
- 00842768011849 FDA UDI
- FDA Product Code
- CZX FDA UDI
- GMDN Term
- Haemopexin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5490 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemopexin IVD, reagent
N Antiserum to Human Hemopexin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemopexin IVD, reagent.
- Antiserum to Human Hemopexin — KENT LABORATORIES, INC. · Class II
- Hemopexin RID plate package — KENT LABORATORIES, INC. · Class I
- Hemopexin RID plate kit — KENT LABORATORIES, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 6f4e8dd1-de63-4ae8-b069-67de1ea80140 36 fields · synced May 30, 2026