SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
10304-118-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas MTB-RIF/INH
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
Product Code
Identification name
09040617190
Test kit package size
192
Identification name
09040625190
Identification name
09051953190
Identification name
08185476001
Identification name
07833342190
Test Package Size
for cobas 6800/8800 systems only
Identification name
07002238190
Test Package Size
for cobas 6800/8800 systems only