In the interest of protecting public health and safety, the Food and Drug Administration (FDA) hereby provides the lists of companies with issued Special Certificate and failed performance validation conducted by the RITM as of 13 September 2021:
| No. | Product Name | Classification | Cert No. | Name of Company |
| 1 | GenBody COVID-19 Ag
Mfd by: Genbody Inc |
ANTIGEN | SC-COVID19-2020-654 | UC BIOSCIENCES INC. |
| 2 | FaStep COVID-19 Antigen Rapid Test Device (Nasopharyngeal/ Oropharygeal Swab)
Mfd by: Assure Tech (Hangzhou) Co. Ltd |
ANTIGEN | SC-COVID19-2020-597 | INFINITE ALLIANCE MARKETING INC. |
| 3 | GenSureTM COVID-19 IgG / IgM Rapid Test
Mfd by: Hebei Gensure Biotech Inc. |
RAPID/ RTK | SC-COVID19-2021-008 | NUEVA SUNSHINE PHILS., INC |
| 4 | SARS-CoV-2 IgG Screen
Mfd by: IMBIAN LAB LLC. |
RAPID/ RTK | SC-COVID19-2020-760 | KOLONWEL TRADING |
| 5 | GA CoV-2 IgG/ IgM
Mfd by: GA Generic Assays GmbH |
RAPID/ RTK | SC-COVID19-2020-289
SC-COVID19-2020-290 |
KHRIZ PHARMA TRADING INC. |
| 6 | COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)
Mfd by: Lansion Biotechnology Co., Ltd |
ANTIGEN | SC-COVID19-2020-732 | ECO APPLICATION SOLUTIONS |
| 7 | NADAL COVID-19 Ag Test
Mfd by: nal von minden GmbH |
ANTIGEN | SC-COVID19-2020-690 | DIAGNOSTIKA PILIPINAS, INC |
| 8 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (Specimen: Nasal Swab)
Mfd by: JOYSBIO (Tianjin) Biotechnology Co., Ltd. |
ANTIGEN | SC-COVID19-2021-103 | EHD SOLUTIONS INC |
| 9 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (Specimen: Nasal Swab)
Mfd by: JOYSBIO (Tianjin) Biotechnology Co., Ltd. |
ANTIGEN | SC-COVID19-2020-715 | TOUCHSTAR ENTERPRISES |
| 10 | BD Veritor System for Rapid Detection of SARS-CoV-2
Mfd by: Becton, Dickinson and Company-7 Loveton Circle Sparks, MD 21152, USA |
ANTIGEN | SC-COVID19-2020-731 | REBMANN, INCORPORATED |
This FDA Advisory does not cover all the other COVID-19 test kits with similar product name/brand name which are imported/distributed by other companies with valid Special Certificates issued by the FDA.
For more information and inquiries, kindly contact the FDA – Center for Device Regulation, Radiation Health, and Research through e-mail address at [email protected] or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.