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

Updated on October 16, 2020



1. Nucleic Acid Amplification Method
No. Product name Marketing Authorization Holder Type Date of Authorization
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
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
GENECUBE SARS-CoV-2 TOYOBO CO., LTD. Nucleic acid
(RT-PCR)
July 2, 2020
TRCReady SARS-CoV-2 TOSOH CORPORATION Nucleic acid
(TRC)
July 31, 2020
10 SmartAmp SARS-CoV-2 K.K. DNAFORM Nucleic acid
(SmartAmp)
August 17, 2020
11 Aptima SARS-CoV-2 Hologic Japan, Inc. Nucleic acid
(TMA)
August 18, 2020
12 Ampdirect 2019-nCoV Detection Kit SHIMADZU CORPORATION Nucleic acid
(RT-PCR)
September 8, 2020
13 i-densy Pack SARS-CoV-2 ARKRAY Factory, Inc. Nucleic acid
(RT-PCR)
September 8, 2020

2. Antigen Test 
No. Product name Marketing Authorization Holder Type Date of Authorization Review
Outline
ESPLINE SARS-CoV-2 Fujirebio Inc. Antigen
(simple kit)
May 13, 2020 Review
Outline
Lumipulse G SARS-CoV-2 Ag Fujirebio Inc. Antigen
(quantitative test)
June 19, 2020
QuickNavi-COVID19 Ag Denka Co., Ltd. Antigen
(simple kit)
August 11, 2020
ImunoAce SARS-CoV-2
Capilia SARS-CoV-2
TAUNS LABORATORIES, INC. Antigen
(simple kit)
October 13, 2020
Lumipulse Presto SARS-CoV-2 Ag Fujirebio Inc. Antigen
(quantitative test)
October 16, 2020