Abbott HBV Sequencing

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Dostupné s:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Třída:

Class C IVD

Výrobce:

Abbott Molecular Inc

Terapeutické oblasti:

Immunology

Terapeutické indikace:

Abbott HBV Sequencing is an in vitro assay for determining the DNA sequence of the reverse transcriptase (RT) region of the polymerase (pol) gene of Hepatitis B Virus (HBV). The test is intended for use as an aid in the management of patients with chronic HBV. The Abbott HBV Sequencing assay is not intended for use in the screening of blood, plasma, or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

Přehled produktů:

Models: Abbott HBV Sequencing Controls - 3N03-80, Abbott HBV Sequencing Reagent Kit - 3N03-90, Abbott HBV Sequencing m2000 System Combined Application CD-ROM v1.0 or above - 5N62-XX, Abbott m2000sp - E Series - 9K14-02, Abbott m2000rt - 9K15-01, Abbott m24sp - 3N06-01, ABBOTT mSample Preparation System DNA Reagents - 6K12-24, Abbott m24sp Script Database Software v6.xx or above - 50-148360, Abbott m2000rt Software Release 6.0 - 50-148401, Abbott m2000sp Software Release 6.0 - 50-148400, Abbott m2000sp Software Release 8.0 - 50-148393, Abbott m2000rt Software Release 8.0 - 50-148392, Abbott m2000sp Software Release 8.1 - 50-148440, Abbott m2000rt Software Release 8.1 - 50-148441

Datum autorizace:

2013-05-29