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

Updated on November 30, 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
27 Xpert Xpress SARS-CoV-2/Flu‘Cepheid’ Beckman Coulter, Inc. Nucleic acid
(RT-PCR)
April 14, 2021
28 DetectAmp SARS-CoV-2 RT-PCR Kit Sysmex Corporation Nucleic acid
(RT-PCR)
April 14, 2021
29 DELBio Dagane G1 SARS-CoV-2 Detection Kit DELTA ELECTRONICS (JAPAN), INC. Nucleic acid
(RT-PCR)
May 27, 2021
30 SGNP nCoV PCR detection kit SUDx-Biotec Corporation Nucleic acid
(RT-PCR)
May 27, 2021
31 Swiftgene SARS-CoV-2 KAINOS KAINOS Laboratories, Inc. Nucleic acid
(Isothermal Amplification)
May 31, 2021
32 TRexGene SARS-CoV-2 Detection kit TOYOBO CO., LTD. Nucleic acid
(RT-PCR)
June 3, 2021
33 ELITe MGB SARS-CoV-2 PCR Detection Kit Precision System Science Co., Ltd. Nucleic acid
(RT-PCR)
June 21, 2021
34 KANEKA Direct RT-PCR kit SARS-CoV-2 KANEKA CORPORATION Nucleic acid
(RT-PCR)
June 25, 2021
35 FTD SARS-CoV2 Kit Siemens Healthcare Diagnostics K.K. Nucleic acid
(RT-PCR)
November 17, 2021
36 μTASWako SARS-CoV-2 FUJIFILM Wako Pure Chemical Corporation Nucleic acid
(RT-PCR)
November 30, 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
(quantitative 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
20 COVID-19 and Influenza A+B Antigen Combo Test (NichireiBio) Nichirei Biosciences Inc. Antigen
(simple kit)
April 14, 2021
21 ImmunoArrow SARS-CoV-2 TOYOBO CO., LTD. Antigen
(simple kit)
May 12, 2021
22 VITROS SARS-CoV-2 Antigen ORTHO-CLINICAL DIAGNOSTICS K.K. Antigen
(quantitative test)
May 12, 2021
23 Check MR-COV19 dotest COV19 ROHTO Pharmaceutical Co., Ltd. Antigen
(simple kit)
May 27, 2021
October 11, 2021
24 RapidTesta SARS-CoV-2 SEKISUI MEDICAL CO., LTD. Antigen
(simple kit)
June 9, 2021
25 AFIAS COVID-19 Ag Test Cartridge TOKYO BOEKI MEDISYS INC. Antigen
(qualitative test)
June 16, 2021
26 QuickNavi-Flu+COVID19 Ag Denka Co., Ltd. Antigen
(simple kit)
June 16, 2021
27 STANDARDTM Q COVID-19 Ag Test MALCOM COMPANY LIMITED Antigen
(simple kit)
August 13, 2021
28 ESPLINE SARS-CoV-2&FLU A+B FUJIREBIO INC. Antigen
(simple kit)
August 13, 2021
29 Quampas COVID-19 Antigen Test Kit Cellspect Co.,Ltd. Antigen
(simple kit)
September 14, 2021
30 Immunofine SARS-COV-2 Nichirei Biosciences Inc. Antigen
(simple kit)
September 14, 2021
31 CL AIA-PACK SARS-CoV-2-Ag TOSOH CORPORATION Antigen
(quantitative test)
September 14, 2021
32 ImunoAce SARS-CoV-2 Ⅱ/
Capilia SARS-CoV-2 Ⅱ
TAUNS Laboratories,Inc. Antigen
(simple kit)
November 8, 2021
33 KBM LineCheck nCoV/Flu KOHJIN BIO CO., LTD. Antigen
(simple kit)
November 8, 2021
34 Quick Chaser SARS-CoV-2/Flu MIZUHO MEDY Co.,Ltd Antigen
(simple kit)
November 17, 2021
35 Quick Chaser SARS-CoV-2/Flu A,B MIZUHO MEDY Co.,Ltd Antigen
(simple kit)
November 17, 2021
36 Accuraseed SARS-CoV-2Ag FUJIFILM Wako Pure Chemical Corporation Antigen
(simple kit)
November 30, 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
9 HISCL TARC Assay Kit SHIONOGI & CO., LTD. TARC (CCL17) June 7, 2021
10 Chemilumi IL6
(ADVIA Centaur/Atellica IM IL6)
Siemens Healthcare
Diagnostics K.K.
IL-6 July 2, 2021
11 Smart Gene Flu A,B MIZUHO MEDY Co.,Ltd Nucleic acid
(RT-PCR)
November 30, 2021

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