Saudi Arabia SFDA registration ME0000001481SFDAA00385
BN II System
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·General IVD(Others)ActiveProduct information
A device for plasma protein analysis.
Product use
The BN™ II System and its nephelometric technology provide uncompromising performance in plasma protein analysis. The menu covers assays to support a variety of clinical indications, such as cardiac risk assessment, kidney diseases, nutritional assessment, and innovative markers such as monoclonal kappa and lambda free light chains, Cystatin C and Carbohydrate-Deficient Transferrin (CDT).
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00385
- Authorization ID
- GHTF-2016-2404
- Status
- Active
- Expire Date
- December 24, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Gmbh
Model information
- Model ID(s)
- OVIA11
Product accessories
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About this record
Access comprehensive regulatory information for BN II System in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000001481SFDAA00385 and manufactured by Siemens Healthcare diagnostics products Gmbh.
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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