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Alinity m HBV Assay | 合法醫療器材資訊網

Alinity m HBV Assay

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 Alinity m HBV Assay

INTENDED USE

The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings.

This assay is not intended to be used in screening blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection.

LIMITATIONS OF THE PROCEDURE

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Alinity m Sample Tubes and Sample Preparation Kits | 合法醫療器材資訊網
Product Name, Unit Size, Order Number, GTIN. Alinity m Aliquot Tube (CE), 1600 each,1 case, 09N49-013, 00884999048195. Alinity m LRV Tube (CE), 12 each ... Read More
Alinity m HIV 1 Assay | 合法醫療器材資訊網
Alinity m HIV-1 Calibration Kit (CE), 4 sets, Cal A and Cal B, 08N45-070, 00884999047150. Alinity m Sample Prep Kit 2 (CE), 8 Bottles-ElutionBuffer2/ ... Read More
Alinity m STI Assay | 合法醫療器材資訊網
Alinity m STI AMP Kit (CE), 384 tests, 4 AMP and ACT Trays, 09N17-090 ... Alinity m Sample Prep Kit 1 (CE), 8 Bottles-ElutionBuffer2/Microparticle2, 09N18-001 ... Read More
SARS-CoV | 合法醫療器材資訊網
2020年5月5日 — The Alinity m System provides automated sample preparation using the ... Each Alinity m SARS-CoV-2 AMP TRAY 1 (individually packed in a ... Read More
Alinity m HBV Assay | 合法醫療器材資訊網
THE ALINITY M HBV ASSAY DELIVERS ACCURATE AND TIMELY VIRAL ... (​refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS ... Read More
Alinity m SARS-CoV | 合法醫療器材資訊網
Alinity m SARS-CoV-2 assay, for use under FDA Emergency Use Authorization only and ... Simple workflow with primary sample tube loading or pooled upper respiratory samples ... and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug Read More
Alinity M Product Overview | 合法醫療器材資訊網
Alinity m delivers true random access; continuous loading for samples, reagents, commodities and access to waste; fast time to first result; and high throughput. Read More
SARS-CoV | 合法醫療器材資訊網
During the sample preparation protocol, SARS-CoV-2 virions are disrupted by ... Each Alinity m SARS-CoV-2 AMP TRAY 1 (individually packed in a foil pouch) ... Read More
Alinity m HIV | 合法醫療器材資訊網
2020年7月1日 — The steps of the Alinity m HIV-1 assay consist of sample preparation, RT-PCR assembly, amplification/detection, and result calculation and ... Read More
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