Saudi Arabia SFDA registration ME0000002988SFDAA00004
ARCHITECT TSH Reagent Kit
Saudi Arabia·Chemicals·Abbott Ireland Diagnostics Division·General IVD(Others)ActiveProduct 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
- Manufacturer Name
- Abbott Ireland Diagnostics Division
Model information
- Model ID(s)
- 7K62-20,7K62-25,7K62-30,7K62-35,
Product accessories
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About this record
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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