SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
10306-118-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas MTB
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
MTBC NAT (with or without drug resistance detection)
Regulatory Version Submitted To PQ
Regulation (EU) 2017/746: Annex IX Certificate
Applicant organization
Roche Diagnostics GmbH
Sandhofer Strasse 116
Penzberg,
82377
Germany
Pathogen
Mycobacterium tuberculosis complex (MTBC)
Specimen Type
Bronchoalveolar lavage fluid
Sputum
Other
Product Code
Identification name
09040579190
Test kit package size
384
Identification name
09040587190
Identification name
09051953190
Identification name
08185476001
Identification name
07544812190
Test Package Size
only for 6800/8800 instruments
Identification name
07002238190
Test Package Size
only for 6800/8800 instruments