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BD ProbeTecโ„ข ET Accessories - SFDA Registration ME0000002812SFDAA00070

Access comprehensive regulatory information for BD ProbeTecโ„ข ET Accessories 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 ME0000002812SFDAA00070 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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General IVD(Others)
ME0000002812SFDAA00070
BD ProbeTecโ„ข ET Accessories
SFDA Registration: ME0000002812SFDAA00070
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Product Information

For direct qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA

Product Use

The BD ProbeTecโ„ข ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viperโ„ข instrument.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002812SFDAA00070
Authorization ID
GHTF-2014-0242
Status
Active
Expire Date
February 24, 2017
Manufacturer
Model Information
Model ID(s)
440457
Product Accessories

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