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Atellica IM fPSA CAL - SFDA Registration ME0000001435SFDAA00967

Access comprehensive regulatory information for Atellica IM fPSA CAL in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000001435SFDAA00967 and manufactured by Siemens Healthcare diagnostics Inc.

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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Annex II List B
ME0000001435SFDAA00967
Atellica IM fPSA CAL
SFDA Registration: ME0000001435SFDAA00967
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Product Information

Calibrator for free prostate-specific antigen assay

Product Use

The Atellicaโ„ข IM Free Prostate-Specific Antigen Calibrator (fPSA CAL) is for in vitro diagnostic use in calibrating the Atellica IM fPSA assay using the Atellicaโ„ข IM Analyzer.

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001435SFDAA00967
Authorization ID
GHTF-2017-0252
Status
Active
Expire Date
December 31, 2019
Manufacturer
Model Information
Model ID(s)
10995578
Product Accessories

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