SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
10307-04545-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Loopamp MTBC Detection Kit
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
MTBC NAT (with or without drug resistance detection)
Applicant organization
Eiken Chemical Co., Ltd.
4.-19-9 Taito
Taito-ku, Tokyo,
Tokyo
110-8408
Japan
Pathogen
Mycobacterium tuberculosis complex (MTBC)
Specimen Type
Sputum
Product Code
Identification name
972000
Test kit package size
96
Test Package Size
MTBC detection reagent - 2x 48 tubes, Positive control MTB (PC MTB) - 1 x 0
Identification name
970000
Test kit package size
90
Test Package Size
heating tube (1x 90 tubes), adsorbent tube (1 x 90 tubes), injection cap (1 x 90 caps)
Identification name
971000
Test kit package size
384
Test Package Size
1 x Pipette-60, filtered tip (4 x 96 tips/box)