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BN II System - SFDA Registration ME0000001481SFDAA00385

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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General IVD(Others)
ME0000001481SFDAA00385
BN II System
SFDA Registration: ME0000001481SFDAA00385
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Product Information

A device for plasma protein analysis.

Product Use

The BNโ„ข 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
Model Information
Model ID(s)
OVIA11
Product Accessories

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