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ARCHITECT TSH Reagent Kit - SFDA Registration ME0000002988SFDAA00004

Access comprehensive regulatory information for ARCHITECT TSH Reagent Kit 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 ME0000002988SFDAA00004 and manufactured by Abbott Ireland Diagnostics Division.

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)
ME0000002988SFDAA00004
ARCHITECT TSH Reagent Kit
SFDA Registration: ME0000002988SFDAA00004
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Product Information

For the quantitative determination of human thyroid

Product Use

ARCHITECT TSH assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of human thyroid stimulating hormone (TSH) in human serum and plasma

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002988SFDAA00004
Authorization ID
GHTF-2016-0821
Status
Active
Expire Date
March 27, 2019
Manufacturer
Model Information
Model ID(s)
7K62-20,7K62-25,7K62-30,7K62-35,
Product Accessories

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