SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
10308-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert MTB/XDR
Assay Type
NAT - PCR
IVD Public Report Category
MTBC NAT (with or without drug resistance detection)
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
Cepheid AB
Röntgenvägen 5
Solna,
17127
Sweden
Pathogen
Mycobacterium tuberculosis complex (MTBC)
Specimen Type
Sputum
Sputum (concentrated sputum sediments)
Product Code
Identification name
GXMTB/XDR-10
Test kit package size
10
Test Package Size
test cartridges, disposables 1ml transfer device, sample reagent, CD with ADF, IFU and instructions how to download the ADF