List of Authorized In Vitro Diagnostics (IVDs) for COVID-19

Updated on June 2   

No. Product name Marketing Authorization Holder Type Date of Authorization Review
Outline
2019-nCoV Fluorescence
Detection Real-time RT-PCR
Kit
Sysmex Corporation Nucleic acid
(RT-PCR)
March 27, 2020
Loopamp Novel Coronavirus
2019 (SARS-CoV-2) Detection Kit
Eiken Chemical Co., Ltd. Nucleic acid
(LAMP)
March 31, 2020
cobas SARS-CoV-2 Roche Diagnostics K.K. Nucleic acid
(RT-PCR)
April 7, 2020
TaqPath Real Time PCR
Reagent Kit for SARS-CoV-2
Life Technologies Japan Ltd. Nucleic acid
(RT-PCR)
April 20, 2020
Xpert Xpress SARS-CoV-2
‘Cepheid’
Beckman Coulter, Inc. Nucleic acid
(RT-PCR)
May 8, 2020
ESPLINE SARS-CoV-2 Fujirebio Inc. Antigen May 13, 2020 Review
Outline
MEBRIGHT SARS-CoV-2 Kit MEDICAL&BIOLOGICAL
LABORATORIES CO., LTD.
Nucleic acid
(RT-PCR)
May 21, 2020
FilmArray Respiratory
Panel 2.1
bioMérieux Japan Ltd. Nucleic acid
(RT-PCR)
June 2, 2020