Other Management Information(Voluntary Disclosure)
1. Title KFDA approval on COVID-19 diagnostic kits for Delta·Omicron variants
2. Details
1. Approved by
Ministry of Food and Drug Safety

2. Usage
In vitro diagnostic medical device that detects COVID-19 genes and variants in human nasopharyngeal swab and oropharyngeal swab with qRT-PCR methodology

3. Classification
IVD reagents for infectious disease marker

4. Product Name
- AccuPower® SARS-CoV-2 Variants ID3 Kit-A (SMVR3-2112)
- AccuPower® SARS-CoV-2 Variants ID3 Kit-B (SMVR3-2113)

5. Product License No.
In-vitro license No. 22-65, 22-66

6. Others
The company aims to proactively respond to the demands of its core markets such as Latin America and the Middle East
3. Decision(Confirmation) Date 2022-01-27
4. Other references concerning investment decisions

- The decision (confirmation) date above is the date of the Ministry of Food and Drug Safety delivered an official letter of amended approval to export in-vitro diagnostic medical devices.
※ Title and date of other disclosure related to this one 2022-01-27 Other Management Information(Voluntary Disclosure)(식약처, 코로나19 델타, 오미크론 구분 진단 키트 수출용 허가)

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Bioneer Corporation published this content on 28 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 January 2022 03:25:09 UTC.