Bioneer : Other Management Information(Voluntary Disclosure) (Obtained an amended approval from KFDA on Covid-19 diagnostic kits compatible with other companies' equipment)
January 05, 2022 at 03:53 am EST
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Other Management Information(Voluntary Disclosure)
1. Title
Obtained an amended approval from KFDA on Covid-19 diagnostic kits compatible with other companies' equipment
2. Details
1. Approved by
Ministry of Food and Drug Safety
2. Contents Approved
Amended approval on :
- Improved performance compared to an existing kit
- Addition of saliva as a testing sample
- Capable of pool testing up to five samples
3. Classification
IVD reagents for infectious disease marker
4. Product Name
AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit (SCVM-2112/2132/2142)
6. Others
SCVM-2112/2132/2142 Kits are compatible with PCR equipment of Thermo Fischer and Bio-Rad (ABI7500 Fast, QuantumStudio™, CFX96 Dx), in addition to BIONEER's ExiCycler™ series. It is capable of diagnosis of SARS-CoV-2, a Covid-19 pathogen.
3. Decision(Confirmation) Date
2021-12-30
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.
- Products obtained an amended approval have differences in test numbers and types. (SCVM-2112, 2132, 2142)
- SCVM-2112: 100TEST, tube type.
- SCVM-2132: 400TEST, tube type.
- SCVM-2142: 384TEST, plate type.
※ Title and date of other disclosure related to this one
2021-12-31 Other Management Information(Voluntary Disclosure)(식약처, 타사 장비 호환 가능한 코로나19 진단키트 수출용 변경 허가)
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Disclaimer
Bioneer Corporation published this content on 05 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 January 2022 08:42:31 UTC.
Bioneer Corp is a Korea-based company engaged in the biotechnology business. The Company mainly operates genetic research, molecular diagnostics, probiotics, and RNA interference (RNAi) new drug development businesses. The Company mainly provides services such as gene analysis and synthesis, gene expression, and protein expression and purification. The Companyâs products include body fat-reducing lactic acid bacteria in probiotics field, and basic materials, reagents, kits, gene extraction, amplification, quantitative analysis equipment, molecular diagnosis equipment for genetic research and molecular diagnosis used in molecular diagnosis field. The company also provides laboratory equipment, single products, and laboratory consumables used in biotech research.
Bioneer : Other Management Information(Voluntary Disclosure) (Obtained an amended approval from KFDA on Covid-19 diagnostic kits compatible with other companies' equipment)
BIONEER CORPORATION 
