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ARCHITECT i Theophylline Reagent Kit - SFDA Registration ME0000002987SFDAA00149

Access comprehensive regulatory information for ARCHITECT i Theophylline 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 ME0000002987SFDAA00149 and manufactured by Abbott GmbH. and Co. KG.

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)
ME0000002987SFDAA00149
ARCHITECT i Theophylline Reagent Kit
SFDA Registration: ME0000002987SFDAA00149
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Product Information

Reagent for quantitative measurement of theophylline in human serum or plasma.

Product Use

The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA)for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00149
Authorization ID
GHTF-2018-1102
Status
Active
Expire Date
April 02, 2021
Manufacturer
Manufacturer Name
Abbott GmbH. and Co. KG
Model Information
Model ID(s)
1P29-25
Product Accessories

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