List of Authorized In Vitro Diagnostics (IVDs) for COVID-19
Updated on June 21, 2024
1. Nucleic Acid Amplification Method
| No. | Product name | Marketing Authorization Holder |
Type | Date of Authorization |
Review Outline |
| 1 | 2019-nCoV Fluorescence Detection Real-time RT-PCR Kit | Sysmex Corporation | Nucleic acid （RT-PCR） |
March 27, 2020 | ― |
| 2 | Loopamp Novel Coronavirus 2019 (SARS-CoV-2) Detection Kit | Eiken Chemical Co., Ltd. | Nucleic acid （LAMP） |
March 31, 2020 | ― |
| 3 | cobas SARS-CoV-2 | Roche Diagnostics K.K. | Nucleic acid （RT-PCR） |
April 7, 2020 | ― |
| 4 | TaqPath Real Time PCR Reagent Kit for SARS-CoV-2 | Life Technologies Japan Ltd. | Nucleic acid （RT-PCR） |
April 20, 2020 | ― |
| 5 | Xpert Xpress SARS-CoV-2 ‘Cepheid’ | Beckman Coulter, Inc. | Nucleic acid （RT-PCR） |
May 8, 2020 | ― |
| 6 | MEBRIGHT SARS-CoV-2 Kit | MEDICAL＆BIOLOGICAL LABORATORIES CO., LTD. | Nucleic acid （RT-PCR） |
May 21, 2020 | ― |
| 7 | FilmArray Respiratory Panel 2.1 | bioMérieux Japan Ltd. | Nucleic acid （RT-PCR） |
June 2, 2020 | ― |
| 8 | GENECUBE SARS-CoV-2 | TOYOBO CO., LTD. | Nucleic acid （RT-PCR） |
July 2, 2020 | ― |
| 9 | 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 | ― |
| 37 | J-Bio Rapid PCR Kit SARS-CoV-2 | Japan Biotechno Pharma Co.,Ltd | Nucleic acid （RT-PCR） |
December 23, 2021 | ― |
| 38 | BD SARS-CoV-2/Flu for BD MAX System | Becton, Dickinson and Company | Nucleic acid （RT-PCR） |
January 31, 2022 | ― |
| 39 | GeneSoC SARS-CoV-2 N2 Detection Kit | KYORIN Pharmaceutical Co., Ltd. | Nucleic acid （RT-PCR） |
March 2, 2022 | ― |
| 40 | LumiraDx SARS-CoV-2 RNA STAR Complete | LumiraDx Japan Co., Ltd. | Nucleic acid （RT-PCR） |
March 31, 2022 | ― |
| 41 | GENECUBE HQ SARS-CoV-2/RSV | TOYOBO CO., LTD. | Nucleic Acid （RT-PCR） |
April 6, 2022 | ― |
| 42 | GSARS-CoV-2 RNA detection kit LAMPdirect | CANON MEDICAL SYSTEMS CORPORATION | Nucleic Acid (LAMP) |
April 8, 2022 | ― |
| 43 | ELITe MGB SARS-CoV-2 PLUS PCR Detection Kit | Precision System Science Co., Ltd. | Nucleic acid （RT-PCR） |
September 14, 2022 | ― |
| 44 | ID NOW COVID-19 2.0 | Abbott Diagnostics Medical Co., Ltd. | Nucleic acid (Isothermal Amplification) |
September 22, 2022 | ― |
| 45 | LeaDEA VIASURE SARS-CoV-2 PCR Kit | Precision System Science Co., Ltd. | Nucleic acid （RT-PCR） |
October 6, 2022 | ― |
| 46 | cobas Liat SARS-CoV-2 | Roche Diagnostics K.K. | Nucleic acid （RT-PCR） |
October 25, 2022 | ― |
| 47 | TRexGene SARS-CoV-2 & FluA/B Detection kit | TOYOBO CO., LTD. | Nucleic acid （RT-PCR） |
November 8, 2022 | ― |
| 48 | Xpert Xpress CoV-2/Flu/RSV plus ‘Cepheid’ | Beckman Coulter, Inc. | Nucleic acid （RT-PCR） |
December 26, 2022 | ― |
| 49 | QIAstat-Dx Respiratory SARS-CoV-2 Panel | QIAGEN K.K. | Nucleic acid （RT-PCR） |
March 22, 2023 | ― |
| 50 | Whole In One SARS-CoV-2 Direct Detection Kit | NIPPON GENE CO., LTD. | Nucleic acid （RT-PCR） |
March 24, 2023 | ― |
| 51 | TaqPath SARS-CoV-2＆Flu＆RSV Real-Time PCR Detection Kit | Life Technologies Japan Ltd. | Nucleic acid （RT-PCR） |
May 12, 2023 | ― |
| 52 | Panther Fusion SARS-CoV-2/Flu A/B/RSV | Hologic Japan, Inc. | Nucleic acid （RT-PCR） |
June 16, 2023 | ― |
| 53 | BioFire SpotFire R panel | bioMérieux Japan Ltd. | Nucleic acid （RT-PCR） |
August 9, 2023 | ― |
| 54 | cobas SARS-CoV-2 Duo | Roche Diagnostics K.K. | Nucleic acid （RT-PCR） |
August9, 2023 | ― |
| 55 | GENECUBE HQ SARS-CoV-2/RSV 2.0 | TOYOBO CO., LTD. | Nucleic acid （RT-PCR） |
August 9, 2023 | ― |
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［111KB］ 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 | Prime fine Co., Ltd. (succeeded from 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 | ― |
| 37 | ADTest SARS-CoV-2/Flu | ADTEC CO.,LTD. | Antigen (simple kit) |
February 8, 2022 | ― |
| 38 | Primal Screen SARS-CoV-2/Flu | ADTEC CO.,LTD. | Antigen (simple kit) |
February 8, 2022 | ― |
| 39 | ImunoAce SARS-CoV-2/Flu / Capilia SARS-CoV-2 /Flu |
TAUNS Laboratories,Inc. | Antigen (simple kit) |
February 8, 2022 | ― |
| 40 | GLINE-2019-nCoV Ag Kit | MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. | Antigen (simple kit) |
February 10, 2022 | ― |
| 41 | Exdia EK Test COVID-19 Ag | EIKEN CHEMICAL CO.,LTD. | Antigen (qualitative test) |
February 10, 2022 | ― |
| 42 | CLINITEST Rapid COVID-19 Antigen Self-Test | Siemens Healthcare Diagnostics K.K. | Antigen (simple kit) |
February 16, 2022 | ― |
| 43 | ADTest SARS-CoV-2 NEO | ADTEC CO.,LTD. | Antigen (simple kit) |
February 24, 2022 | ― |
| 44 | COVID-19 Antigen Test (NichireiBio) | NICHIREI BIOSCIENCES INC. | Antigen (simple kit) |
March 4, 2022 | ― |
| 45 | ImunoAce SARS-CoV-2 Saliva / Capilia SARS-CoV-2 Saliva | TAUNS Laboratories,Inc. | Antigen (simple kit) |
March 17, 2022 | ― |
| 46 | HEALGEN Rapid COVID-19 Antigen Self-Test | Takara Bio Inc. | Antigen (simple kit) |
March 17, 2022 | ― |
| 47 | LumiraDx SARS-CoV-2 & Flu A/B Test Strip | LumiraDx Japan Co., Ltd. | Antigen (qualitative test) |
March 31, 2022 | ― |
| 48 | Quick Chaser SARS-CoV-2 | MIZUHO MEDY Co.,Ltd | Antigen (simple kit) |
April 19, 2022 | ― |
| 49 |
KANEKA Immunochromatography SARS-CoV-2 Ag |
KANEKA CORPORATION |
Antigen |
May 25, 2022 |
― |
| 50 |
Inspecter Kowa SARS-CoV-2 |
KOWA Co., Ltd. |
Antigen |
June 1, 2022 |
― |
| 51 |
ESPLINE SARS-CoV-2 N |
Fujirebio Inc. |
Antigen (simple kit) |
June 7, 2022 | ― |
| 52 | RapidTesta RSV&SARS-CoV-2 | SEKISUIMEDICAL CO., LTD. | Antigen (simple kit) |
July 1, 2022 | ― |
| 53 | RapidTesta FLU&SARS-CoV-2 | SEKISUIMEDICAL CO., LTD. | Antigen (simple kit) |
July 1, 2022 | ― |
| 54 | SARS-CoV-2 Antigen(CoV2Ag) | Siemens Healthcare Diagnostics K.K. | Antigen (quantitative test) |
July 1, 2022 | ― |
| 55 |
KBM LineCheck nCoV |
KOHJIN BIO CO., LTD. |
Antigen (simple kit) |
July 8, 2022 |
― |
| 56 |
Quick Chaser SARS-CoV-2/RSV |
MIZUHO MEDY Co.,Ltd |
Antigen (simple kit) |
August 10, 2022 | ― |
| 57 | VTRUST SARS-CoV-2 Ag | NIPRO CORPORATION | Antigen (simple kit) |
August 18, 2022 | ― |
| 58 | SARS-CoV-2 & Flu A/B Rapid AntigenTest | Roche Diagnostics K.K. | Antigen (simple kit) |
September 7, 2022 | ― |
| 59 | GLINE-SARS-CoV-2&FluA+B | MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. | Antigen (simple kit) |
September 14, 2022 | ― |
| 60 | ImmunoArrow SARS-CoV-2&FluA/B&RSV | TOYOBO CO., LTD. | Antigen (simple kit) |
October 11, 2022 | ― |
| 61 | TEGARUNA Stick SARS-CoV-2 Ag | Fujinaga Pharmaceutical Co., Ltd. | Antigen (simple kit) |
November 29, 2022 | ― |
| 62 | Quick Chaser Auto SARS-CoV-2/Flu | MIZUHO MEDY Co.,Ltd | Antigen (qualitative test) |
December 26, 2022 | ― |
| 63 | FUJI DRI-CHEM IMMUNO AG CARTRIDGE COVID-19/Flu | MIZUHO MEDY Co.,Ltd | Antigen (qualitative test) |
December 26, 2022 | ― |
| 64 | BIOCREDIT COVID-19 Ag Test Nasal | Rapigen, Inc. | Antigen (simple kit) |
January 12, 2023 | ― |
| 65 | SARS-CoV-2 Rapid Antigen Test 2.0 | Roche Diagnostics K.K. | Antigen (simple kit) |
January 18, 2023 | ― |
| 66 | SARS-CoV-2 & Flu Rapid Antigen Test Kit Rapiim SARS-CoV-2-N/Flu PRT-20101A | CANON MEDICAL SYSTEMS CORPORATION | Antigen (qualitative test) |
March 17, 2023 | ― |
| 67 | RT test immunochromato - SARS-CoV-2 | NISSUI PHARMACEUTICAL CO., LTD. | Antigen (simple kit) |
March 24, 2023 | ― |
| 68 | SARS-CoV-2 Rapid Antigen Test Kit Rapiim SARS-CoV-2-H | CANON MEDICAL SYSTEMS CORPORATION | Antigen (quantitative test) |
April 7, 2023 | ― |
| 69 | FUJI DRI-CHEM IMMUNO AG HANDY COVID-19/Flu | FUJIFILM Corporation | Antigen (simple kit) |
April 28, 2023 | ― |
| 70 | KANEKA Immunochromatography Flu A/B & SARS-CoV-2 Ag | KANEKA CORPORATION | Antigen (simple kit) |
May 12, 2023 | ― |
| 71 | COVID-19 Antigen Test「INNOVITA」 | MED Co., LTD | Antigen (simple kit) |
June 16, 2023 | ― |
| 72 | INDICAID COVID-19 Antigen Test | BIC GROUP Ltd | Antigen (simple kit) |
June 16, 2023 | ― |
| 73 | Panbio COVID-19/Flu A&B Rapid Panel | Abbott Diagnostics Medical Co., Ltd. | Antigen (simple kit) |
June 27, 2023 | ー |
| 74 | SARS-CoV-2 Antigen Rapid Test Kit [GeneticLab] | Eurofins GeneticLab Co., Ltd. | Antigen (simple kit) |
August 9, 2023 | ー |
| 75 | VTRUST SARS-CoV-2+Flu Ag | NIPRO CORPORATION | Antigen (simple kit) |
August 9, 2023 | ー |
| 76 | ＣｈｅｃｋＭＲ－ＣＯＶ１９＋Ｆｌｕ | ROHTO Pharmaceutical Co., Ltd. | Antigen (simple kit) |
October 13, 2023 | ー |
| 77 | ImonoAce SARS-CoV-2 Ⅲ Capilia SARS-CoV-2 Ⅲ |
TAUNS Laboratories, Inc. | Antigen (simple kit) |
November 2, 2023 | ー |
| 78 | ImonoAce SARS-CoV-2 Saliva Ⅱ Capilia SARS-CoV-2 Saliva Ⅱ |
TAUNS Laboratories, Inc. | Antigen (simple kit) |
November 10, 2023 | ー |
| 79 | Rapi COVID-19 test kit | Rosenburg Medical Co. Ltd. | Antigen (simple kit) |
June 21, 2024 | ー |
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 | Influenza virus (A & B) | November 30, 2021 | ― |
| 12 | Exdia EK Test Influenza A+B | EIKEN CHEMICAL CO.,LTD | Influenza virus (A & B) | March 17, 2022 | ― |
| 13 | Lumipulse Presto IL-6 | Fujirebio Inc． | IL-6 | March 31, 2022 | ― |
| 14 | GeneSoC Influenza virus A/B Detection Kit |
KYORIN Pharmaceutical Co., Ltd. |
Influenza virus (A & B) | August 4, 2022 | ― |
| 15 | cobas Liat Flu A/B & RSV | Roche Diagnostics K.K. | Influenza virus (A & B) RS virus |
December 8, 2022 | ― |
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