FUJIREBIO

Automated Procalcitonin (PCT) Test
Lumipulse G B•R•A•H•M•S PCT

Lumipulse G B•R•A•H•M•S PCT immunoreaction cartridges are for in vitro diagnostic (IVD) use with a two-step sandwich immunoassay method on the LUMIPULSE G system for the quantitative determination of procalcitonin (PCT) in human serum and plasma. The CE marked test is the most sensitive fully automated PCT test and the assay utilizes proven CLEIA (chemiluminescent enzyme immunoassay) technology with results that in up to 35 minutes.

COVID-19 Fluorescent RT-Isothermal Assay
iAMP COVID-19 SANO Assay

iAMP COVID-19 SANO Assay is a real-time fluorescent RT-isothermal assay based on Atila’s proprietary isothermal amplification technology. The CE marked assay is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and saliva specimens from individuals with signs and symptoms of infection who are suspected of COVID-19.

SARS-CoV-2 Antigen Test
Lumipulse G SARS-CoV-2 Ag

The CE marked Lumipulse G SARS-CoV-2 Ag is designed for in vitro diagnostic (IVD) use with the Lumipulse G system for the detection and quantitative measurement of SARS-CoV-2 antigen in human nasopharyngeal swab or saliva. The assay is meant to be used as a diagnostic tool for the confirmation of a SARS-CoV-2 infection and utilizes proven CLEIA (chemiluminescent enzyme immunoassay) technology with results available in up to 35 minutes.

SARS-CoV-2 Ag Controls
Lumipulse® SARS-CoV-2 Ag Controls

The CE marked Lumipulse® SARS-CoV-2 Ag Controls are intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analysis of SARS-CoV-2 antigen on the LUMIPULSE G System.

AMH Immunoreaction Cartridges
Lumipulse® G AMH (anti-Müllerian hormone)

The CE marked Lumipulse® G AMH (anti-Müllerian hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the fully automated quantitative measurement of AMH in specimens based a two-step immunoassay method on the LUMIPULSE G System. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.

LH Immunoreaction Cartridges
Lumipulse® G LH (Luteinizing Hormone)

The CE marked Lumipulse® G LH (Luteinizing Hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of luteinizing hormone (LH) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.

COVID-19 Test
iAMP COVID-19 Detection Kit

CE标志着国际COVID-19检测装备设计ned for the qualitative nucleic acid detection of SARS-CoV-2 (COVID-19) on naso- or oropharyngeal swabs without pre-treatment. Using isothermal amplification with real time fluorescence detection, the kit requires limited hands-on time and delivers fast sample-to-result within 75 to 90 minutes only.

SARS-CoV-2 Assay
ESPLINE® SARS-CoV-2

The CE marked ESPLINE® SARS-CoV-2 is a cassette-style immunochromatographic assay for in vitro diagnostic (IVD) use for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab fluid. It can detect SARS-CoV-2 within 30 minutes using a simple procedure without any special instruments and is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.