The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that the following companies with issued Special Certification for COVID-19 Test Kits have voluntarily surrendered their authorization to market the product:
| Company’s Name | Product Name | SC Control Number | Classification | |
| 1 | MDX NETHERLANDS DIAGNOSTICS, INC. | FOSUN COVID-19 RT-PCR DETECTION KIT | SC-COVID19-2020-183 | PCR |
| 2 | MDX NETHERLANDS DIAGNOSTICS, INC. | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019 nCoV | SC-COVID19-2020-148 | PCR |
| 3 | CLEARBRIDGE MEDICAL PHILIPPINE | NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT | SC-COVID19-2020-029 | RAPID |
| 4 | UC BIOSCIENCES INC. | ORIGHT COVID-19 IgG/IgM RAPID TEST KIT | SC-COVID19-2020-250 | RAPID |
| 5 | UC BIOSCIENCES INC. | Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test | SC-COVID19-2020-104 | RAPID |
| 6 | UC BIOSCIENCES INC. | 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) | SC-COVID19-2020-102 | RAPID |
| 7 | BIOPHARMA MEDICAL SOLUTIONS, INC. | SARS-CoV-2 FLUORESCENT PCR | SC-COVID19-2020-079 | PCR |
| 8 | BIOPHARMA MEDICAL SOLUTIONS, INC. | SOLGENT DiaPlexQ™ NOVEL CORONAVIRUS (2019-nCoV) DETECTION KIT | SC-COVID19-2020-090 | PCR |
| 9 | CLEARBRIDGE MEDICAL PHILIPPINES, INC | SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) | SC-COVID19-2020-657 | ANTIGEN |
| 10 | INDOPLAS PHILIPPINES, INC. | SARS-CoV-2 Antibody Test (Lateral Flow Method) – Guangzhou Wondfo Biotech Co., Ltd. | SC-COVID19-2020-091 | RAPID |
| 11 | CRESTLINE SCIENTIFIC CORPORATION | Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test | SC-COVID19-2020-161 | RAPID |
| 12 | MUREX DIAGNOSTIC PRODUCTS SPECIALISTS | SARS-CoV-2 Fluorescent PCR | SC-COVID19-2020-182 | PCR |
| 13 | ADAMSON MEDTEX INTERNATIONAL CORP | DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) – Zhuhai Livzon Diagnostic Inc | SC-COVID19-2020-032 | RAPID |
| 14 | AGLOBAL CARE, INC | 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD)-INNOVITA | SC-COVID19-2020-099 | RAPID |
| 15 | ST. TYKE, INC | PCL COVID19 IgG/IgM RAPID GOLD | SC-COVID19-2020-396 | RAPID |
| 16 | BIOPHARMA MEDICAL SOLUTIONS, INC. | 2019-nCoV Antibody Test (Colloidal Gold) – Innovita (Tangshan) Biological Technology Co., Ltd. | SC-COVID19-2020-157 | RAPID |
| 17 | BIOSITE MEDICAL INSTRUMENTS | MAGLUMI 2019-nCoV IgM/IgG | SC-COVID19-2020-739 | RAPID |
| 18 | MGV SCIECHEM CORPORATION | 2019 n-CoV IgG/IgM RAPID TEST CASSETTE | SC-COVID19-2020-613 | RAPID |
| 19 | HEALTHSOLUTIONS ENTERPRISES, INC | DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) – Zhuhai Livzon Diagnostic Inc. | SC-COVID19-2020-394 | RAPID |
| 20 | HEALTHSOLUTIONS ENTERPRISES, INC | LabGun COVID-19 RT-PCR Kit | SC-COVID19-2020-214 | PCR |
| 21 | HEALTHSOLUTIONS ENTERPRISES, INC | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019 nCoV | SC-COVID19-2020-211 | PCR |
| 22 | HEALTHSOLUTIONS ENTERPRISES, INC | 2019-nCoV NUCLEIC ACID TESTING KIT (FLUORESCENCE PCR METHOD) | SC-COVID19-2020-220 | PCR |
| 23 | HEALTHSOLUTIONS ENTERPRISES, INC | SOLGENT DiaPlexQ™ NOVEL CORONAVIRUS (2019-nCoV) DETECTION KIT | SC-COVID19-2020-213 | PCR |
| 24 | HEALTHSOLUTIONS ENTERPRISES, INC | NOVEL CORONAVIRUS (2019-NCOV) NUCLEIC ACID DETECTION KIT (FLUORESCENCE PCR) | SC-COVID19-2020-222 | PCR |
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.
Attachment:-> FDA-Advisory-No.2021-0520