Abbott RealTime MTB RIF/INH Resistance Amplification Reagent Kit - SFDA Registration ME0000002987SFDAA00391
Access comprehensive regulatory information for Abbott RealTime MTB RIF/INH Resistance 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 ME0000002987SFDAA00391 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 (RIF)&(INH) resistance in MTB.
is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of Rifampicin (RIF) and Isoniazid (INH) resistance in MTB positive samples. The assay will be used to test specimens of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and bronchial alveolar lavage. The assay is intended for use in conjunction with clinical presentation and other laboratory markers for use as an aid in identifying MTB RIF and/or INH resistant MTB strains.
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