List of Authorized In Vitro Diagnostics (IVDs) for COVID-19
Updated on December 8, 2020
1. Nucleic Acid Test
| No. | Product name | Marketing Authorization Holder | Type | Date of Authorization |
| 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 |
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 | ― |
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 | ― |
