Saudi Arabia SFDA registration ME0000001481SFDAA00381
BN ProSpec System
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·General IVD(Others)ActiveProduct information
device for quantitative determination of proteins
in serum, plasma and urine
Product use
"The BN ProSpec provides a quantitative and fully automated determination of plasma proteins by means of ephelometric analysis of serum, plasma, urine and CSF. The instrument is designed for continuous use and has a cooler for reagents and controls (approximately 8*C). Standards must be refrigerated off the instrument immediately after use. The BN ProSpec can perform precipitation and agglutination reactions (latex) quickly and accurately.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00381
- Authorization ID
- GHTF-2017-1506
- Status
- Active
- Expire Date
- December 24, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Gmbh
Model information
- Model ID(s)
- OVLI01
Product accessories
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About this record
Access comprehensive regulatory information for BN ProSpec 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 ME0000001481SFDAA00381 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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