Bio-Rad Virotrol III serology control

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD

class:

Class B IVD

manufactured_by:

Bio-Rad Laboratories

therapeutic_area:

Microbiology

therapeutic_indication:

VIROTROL III intended for use as an unassayed reactive control with in vitro assay procedures for the qualitative determination of Immunoglobulin M antibodies to Hepatitis A Virus (HAV-IgM), Immunoglobulin M antibodies to Hepatitis B core antigen (HBc-IgM), and total antibody to Hepatitis A Virus (anti-HAV). Specific reactivity for Immunoglobulin G antibodies to Hepatitis A Virus has not been established. This product is intended to provide a means of estimating precision and has the potential for detecting systematic deviations from specific laboratory testing procedures.

leaflet_short:

Models: VIROTROL III (1 x 5ml) - 00110A, VIROTROL III (1 x 5ml) - 00110C

authorization_date:

2013-02-15