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FUJIREBIO

Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, development, production and worldwide commercialization of robust IVD products. These span the range from specialized testing to fully automated routine clinical laboratory testing solutions covering a variet...
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Covid-19FUJIREBIO

Clinical Laboratory

Flu A/B & SARS-CoV-2 Real-Time RT-PCR Test
DiaPlexQ Flu A/B & SARS-CoV-2

DiaPlexQ Flu A/B & SARS-CoV-2 is a Real-time RT-PCR test for the qualitative detection of HA gene from Influenza A/B virus and N and ORF1a gene from SARS-CoV-2 in nasopharyngeal swab.
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SARS-CoV-2 (ORF1a N RdRp)实时rt - pcr检测
DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp)

DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp) is a Real-time RT-PCR test for the qualitative detection of SARS-CoV-2 nucleic acids in various sample types.
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Automated Procalcitonin (PCT) Test
Lumipulse G B•R•A•H•M•S PCT

Lumipulse G B•R•A•H•M•S PCT免疫反应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.
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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.
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SARS-CoV-2 S-IgG Antibody Assay
Lumipulse G SARS-CoV-2 S-IgG

Lumipulse G SARS-CoV-2 S-IgG is an assay system, including a set of immunoassay reagents, for the quantitative measurement of IgG-type antibodies SARS-CoV-2 spike protein (SARS-CoV-2 S-IgG) in specimens based on CLEIA technology. The CE marked assay system has a specific two-step immunoassay method and runs on the LUMIPULSE G System with results available in up to 30 minutes.
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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.
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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.
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BNP Control
Lumipulse® BNP Control

The CE marked Lumipulse® BNP Control are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of human B-type natriuretic peptide (BNP) on the LUMIPULSE G Systems.
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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.
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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.
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HIV p24 Antigen Test
INNOTEST® HIV Antigen mAb

The CE marked INNOTEST® HIV Antigen mAb is an enzyme immunoassay for the qualitative detection of HIV p24 antigen in human serum, plasma, and cell culture supernatant. The kit contains reagents for confirmation of HIV p24 antigens in repeatedly reactive samples.
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COVID-19 Test
iAMP COVID-19 Detection Kit

The CE marked iAMP COVID-19 Detection Kit is designed 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.
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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.
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AboutFUJIREBIO

Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, development, production and worldwide commercialization of robust IVD products. These span the range from specialized testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states.
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HPV Genotyping Assay

HPV Genotyping Assay

Model: AmpFire® HPV Screening 16/18/HR
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Description:

The CE marked AmpFire® HPV Screening 16/18/HR kit is intended for fast, simple, and accurate qualitative detection and identification of 15 High-Risk HPV types with simultaneous genotyping of HPV16 and 18 in one tube.

Tags:[Clinical Laboratory], [Ready-to-use Kits for Analysis], [Rapid Tests]
Features Specifications

Features

• Method: Isothermal amplification with real time fluorescence detection
• Simplicity: Extremely simple sample processing - no DNA purification needed; Limited hands-on time
• Fast: Sample-to-result in less than 1.5 hours
• Accurate: High accuracy and sensitivity with all necessary controls
• Flexible: Suitable for different sample types; Flexible sample numbers per run with no waste of reagentsRequest Information

Specifications

• HPV types detected: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
• Sample types: Dry swab samples, Cervical samples stored in ThinPrep® (PreservCyt Solution), SurePathTM, FFPE biopsy, or purified DNA samples.
• Target region: Various regions in the viral genome including E6/E7
• Reaction volume: 25 µL
• Reaction time: Approx. 90 minutes including sample processing
• Equipment: Heating block and real-time PCR system (compatible with CFX96 - Bio-Rad, ABI7500 - Thermo Fisher Scientific, Rotor-Gene Q - QIAGEN, PowerGene 9600 - Atila PCR system, and other RT-PCR systems with 5 fluorescence channels)Request Information

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