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

Updated on March 17, 2021



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
14 ID NOW COVID-19 Abbott Diagnostics Medical Co., Ltd Nucleic acid
(Isothermal Amplification)
October 20, 2020
15 GENECUBE HQ SARS-CoV-2 TOYOBO CO., LTD. Nucleic acid
(RT-PCR)
October 23, 2020
16 SGNP nCoV/Flu PCR Detection Kit SUDx-Biotec Corporation Nucleic acid
(RT-PCR)
October 23, 2020
17 Takara SARS-CoV-2 Direct PCR detection kit Takara Bio Inc. Nucleic acid
(RT-PCR)
October 27, 2020
18 cobas SARS-CoV-2 & Flu A/B Roche Diagnostics K.K. Nucleic acid
(RT-PCR)
November 13, 2020
19 Illumina COVIDSeq Test Illumina K.K. Next Generation Sequencing December 8, 2020
20 TaqPath SARS-CoV-2 Real Time PCR Reagent Kit HT Life Technologies Japan Ltd. Nucleic acid
(RT-PCR)
December 17, 2020
21 TRCReady SARS-CoV-2 i TOSOH CORPORATION Nucleic acid
(TRC)
January 19, 2021
22 Simprova SARS-CoV-2 Detection Kit Eiken Chemical Co., Ltd. Nucleic acid
(LAMP)
February 15, 2021
23 Takara SARS-CoV-2 & Flu Direct PCR detection kit Takara Bio Inc. Nucleic acid
(RT-PCR)
February 15, 2021
24 Smart Gene SARS-CoV-2 MIZUHO MEDY Co.,Ltd Nucleic acid
(RT-PCR)
February 18, 2021
25 Alinity m system SARS-CoV-2 Abbott Japan LLC Nucleic acid
(RT-PCR)
February 24, 2021
26 cobas Liat SARS-CoV-2 & Flu A/B Roche Diagnostics K.K. Nucleic acid
(RT-PCR)
March 12, 2021

2. Antigen Test 
No. Product name Marketing Authorization Holder Type Date of Authorization Review
Outline
1 ESPLINE SARS-CoV-2 Fujirebio Inc. Antigen
(simple kit)
May 13, 2020 Review
Outline
2 Lumipulse G SARS-CoV-2 Ag Fujirebio Inc. Antigen
(quantitative test)
June 19, 2020
3 QuickNavi-COVID19 Ag Denka Co., Ltd. Antigen
(simple kit)
August 11, 2020
4 ImunoAce SARS-CoV-2
Capilia SARS-CoV-2
TAUNS LABORATORIES, INC. Antigen
(simple kit)
October 13, 2020
5 Lumipulse Presto SARS-CoV-2 Ag Fujirebio Inc. Antigen
(quantitative test)
October 16, 2020
6 HISCL SARS-CoV-2 Ag Assay Kit Sysmex Corporation Antigen
(qualitative test)
November 10, 2020
7 SARS-CoV-2 Antigen Rapid Test Kit Rapiim SARS-CoV-2-N PRT-C2N01A CANON MEDICAL SYSTEMS CORPORATION Antigen
(qualitative test)
December 8, 2020
8 LumiraDx SARS-CoV-2 Ag Test Strip LumiraDx Japan Co., Ltd. Antigen
(qualitative test)
January 19, 2021
9 PanbioTM COVID-19 Ag Rapid Test Device(NASOPHARYNGEAL)/ PanbioTM COVID-19 Ag Rapid Test Device(NASAL) Abbott Diagnostics Medical Co., Ltd. Antigen
(simple kit)
January 22, 2021
10 BD Veritor System for Rapid Detection of SARS-CoV-2 Becton, Dickinson and Company Antigen
(qualitative test)
January 26, 2021
11 PRORAST SARS-CoV-2 Ag
ADTest SARS-CoV-2
ADTEC Corporation/LSI Medience Corporation Antigen
(simple kit)
January 29, 2021
12 SARS-CoV-2 Rapid Antigen Test Roche Diagnostics K.K. Antigen
(simple kit)
February 9, 2021
13 FUJI DRI-CHEM IMMUNO AG HANDY COVID-19 Ag FUJIFILM Corporation Antigen
(simple kit)
February 15, 2021
14 Sofia SARS Antigen FIA Quidel Corporation Antigen
(qualitative test)
February 18, 2021
15 Quick Chaser Auto SARS-CoV-2 MIZUHO MEDY Co.,Ltd Antigen
(qualitative test)
March 2, 2021
16 FUJI DRI-CHEM IMMUNO AG CARTRIDGE COVID-19 Ag MIZUHO MEDY Co.,Ltd Antigen
(qualitative test)
March 2, 2021
17 ALSONIC COVID-19 Ag Alfresa Pharma Corporation Antigen
(simple kit)
March 12, 2021
18 KBM LineCheck nCoV (Stick Type) KOHJIN BIO CO., LTD. Antigen
(simple kit)
March 17, 2021
19 Elecsys SARS-CoV-2 Antigen Roche Diagnostics K.K. Antigen
(quantitative test)
March 17, 2021

3. Others 
No. Product name Marketing Authorization Holder Test item Date of Authorization Review
Outline
1 Lumipluse Flu-A&B Fujirebio Inc. Influenza virus (A & B) November 10, 2020
2 GENECUBE FluA/B TOYOBO CO., LTD Influenza virus (A & B) December 21, 2020
3 Lumipulse Presto Flu-A&B Fujirebio Inc. Influenza virus (A & B) December 22, 2020
4 HISCL IFN-λ3 Assay Kit Sysmex Corporation IFN-λ3 December 22, 2020
5 Loopamp Influenza B virus Detection Kit Eiken Chemical Co., Ltd. Influenza virus B February 2, 2021
6 Simprova Influenza A virus Detection Kit Eiken Chemical Co., Ltd. Influenza virus A February 15, 2021
7 Simprova Influenza B virus Detection Kit Eiken Chemical Co., Ltd. Influenza virus B February 15, 2021
8 HISCL Influenza Assay Kit Sysmex Corporation Influenza virus (A & B) February 18, 2021