SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
10295-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert MTB/RIF Ultra
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
MTBC NAT (with or without drug resistance detection)
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Cepheid AB
Röntgenvägen 5
Solna,
17127
Sweden
Pathogen
Mycobacterium tuberculosis complex (MTBC)
Specimen Type
Sputum
Product Code
Identification name
GXMTB-ULTRA-HB-10
Test kit package size
10
Identification name
GXMTB-ULTRA-HB-50
Test kit package size
50