Abbott RealTime MTB Amplification Reagent Kit - SFDA Registration ME0000002987SFDAA00389
Access comprehensive regulatory information for Abbott RealTime MTB Amplification 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 ME0000002987SFDAA00389 and manufactured by Abbott GmbH. & 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.
Qualitative detection of MTB
The Abbott RealTime MTB assay is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of MTB complex DNA in smear positive or smear negative specimens of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and bronchial alveolar lavage collected from individuals suspected of having tuberculosis (TB). The assay is intended for use in conjunction with clinical presentation and other laboratory markers for use as an aid in diagnosing TB infections.
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