Macro & Micro-Test five products approved by U.S. FDA

On January 30th and the occasion of Chinese New Year's Eve, five products developed by Macro & Micro-Test, Easy Amp Real-time Fluorescence Isothermal Detection System, Micro-Test Automatic Nucleic Acid Extractor, Macro & Micro-Test Viral DNA/RNA Kit, Macro & Micro-Test Sample Release Reagent, and Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit have been cleared and approved by US FDA respectively.

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The food, drug, cosmetics and medical devices approved by U.S. Food and Drug Administration (FDA), internationally recognized as the authority for medical devices approval, are the products investigated and authorized by global authoritative standards. The above five FDA-authorized products from Macro & Micro-Test cover the whole process of nucleic testing. 

 

1. Sampling

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Two different sizes, universal breakable flocked swab, effective virus inactivation, applicable for mixed detection.

2. Nucleic Acid Extraction
● Program A

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Macro & Micro-Test Viral DNA/RNA Kit
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Automatic Nucleic Acid Extractor

The Automatic Nucleic Acid Extractor is operated with one bottom only, freeing the hands of medical staff. With Macro & Micro-Test Viral DNA/RNA Kit, the nucleic acid extraction process can be completed in 10 minutes, highly accelerating the work and reducing the burdens on laboratories.

● Program B

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Macro & Micro-Test Sample Release Reagent

The spread of SARS-CoV-2 Virus has brought enormous pressure to medical staff and laboratories, who have difficulties in carrying out high-volume tests restricted by space, time, equipment and manpower. Considering this, Macro & Micro-Test has developed the one-step direct amplification solution: sample extraction in 5 minutes without any instrument assistance.

3. Isothermal Amplification

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Compared with the traditional PCR testing, Easy Amp Real-time Fluorescence Isothermal Detection System, with positive result in 5 minutes, has reduced the whole detection process by 2/3. It's 4x4 independently designed modules ensure the on-demand testing with more accurate result in three steps.

May you happy new year and the year of tiger full of happiness.


Post time: Aug-01-2022