Saudi Arabia SFDA registration ME0000002812SFDAA00074
BD ProbeTec™ ET Mycobacterium tuberculosis (DTB)
Saudi Arabia·Chemicals·Becton Dickinson and Company·General IVD(Others)ActiveProduct information
For direct qualitative
detection of Mycobacterium tuberculosis complex DNA
Product use
The BD ProbeTec™ ET Mycobacterium tuberculosis Complex (DTB) Direct Detection Reagent Pack, for use with the BD ProbeTec ET System, utilizes Strand Displacement Amplification (SDA) technology for the direct qualitative detection of Mycobacterium tuberculosis complex DNA from decontaminated, digested clinical respiratory samples such as sputa, induced sputa, bronchial washings and other respiratory specimens.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002812SFDAA00074
- Authorization ID
- GHTF-2014-0242
- Status
- Active
- Expire Date
- February 24, 2017
Manufacturer
- Manufacturer Name
- Becton Dickinson and Company
Model information
- Model ID(s)
- 440610
Product accessories
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About this record
Access comprehensive regulatory information for BD ProbeTec™ ET Mycobacterium tuberculosis (DTB) 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 ME0000002812SFDAA00074 and manufactured by Becton Dickinson and Company.
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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