Saudi Arabia SFDA registration ME0000002992SFDAA00154
Alinity m SYSTEM
Saudi Arabia·Chemicals·Abbott Molecular Inc.·General IVD(Others)ActiveProduct information
System is designed to automate the steps for nucleic acid testing.
Product use
intended for use by a trained laboratory professional to perform RealTime PCR on clinical specimens to provide quantitative and qualitative detection of nucleic acid sequences for diagnostic purposes. The intended use of the system comprises automatic performance of the following functions: • Isolation of nucleic acids from specimens.
• Amplification of specific nucleic acid. targets by PCR.
• Detection of the amplified product.
• Analysis of the response data to produce quantitative or qualitative results.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002992SFDAA00154
- Authorization ID
- GHTF-2019-1659
- Status
- Active
- Expire Date
- August 08, 2022
Manufacturer
- Manufacturer Name
- Abbott Molecular Inc.
Model information
- Model ID(s)
- 08N53-002
Product accessories
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About this record
Access comprehensive regulatory information for Alinity m SYSTEM 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 ME0000002992SFDAA00154 and manufactured by Abbott Molecular 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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