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AAT Reagent - SFDA Registration ME0000004466SFDAA00008

Access comprehensive regulatory information for AAT Reagent 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 ME0000004466SFDAA00008 and manufactured by Ortho Clinical 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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General IVD(Others)
ME0000004466SFDAA00008
AAT Reagent
SFDA Registration: ME0000004466SFDAA00008
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Product Information

Chemistry Products Antitrypsin Reagent

Product Use

VITROS Chemistry Products AAT Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure ฮฑ1-antitrypsin concentration in human serum. The measurement of ฮฑ1-antitrypsin (AAT) concentration in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000004466SFDAA00008
Authorization ID
GHTF-2016-1288
Status
Active
Expire Date
March 02, 2019
Manufacturer
Model Information
Model ID(s)
6802216
Product Accessories

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