Acumen Research Laboratories AcuSept

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

ACUMEN RESEARCH LABORATORIES PTE. LTD.

수업:

Class C IVD

Manufactured by:

Acumen Research Laboratories Pte Ltd.

치료 영역:

Microbiology

치료 징후:

AcuSept® is a non-automated, semi-quantitative RT-qPCR in vitro gene expression assay for diagnosing sepsis by quantifying leukocyte RNA extracted from whole blood, and profiling the relative expression levels of 19 host genes responsive to sepsis. AcuSept® is validated for use on Roche LightCycler® 480 Instrument II and is for professional use only. AcuSept® is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to identify patients with low or high risk of sepsis. AcuSept® is not indicated for predicting or detecting response to therapy.

제품 요약:

Device System Info:[System or Procedure Pack], AcuSept is composed of two IVD kits in addition to its accompanying AcuSept Diagnostic Score Calculator Software mandatory for diagnostic score calculation. Kit A consists of reverse transcription and RT-qPCR reagents, while Kit B holds RT-qPCR plates.; Models: AcuSept Kit A - 19001001, AcuSept Kit B - 19001002, AcuSept Diagnostic Score Calculator Software - 19001012

승인 날짜:

2021-03-30