The Food and Drug Administrative (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 Flourescent 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-2 ANTIBODY
TEST (COLLOIDAL GOLD) |
SC-COVID19-
2020-102 |
RAPID |
7. |
Biopharma Medical Solutions, Inc. | SARS-CoV-2 FLOURESCENT 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 | SC-COVID19- 2020-657 |
RAPID |
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 Flourescent PCR |
SC-COVID19- 2020-182 |
PCR |
13. |
Adamson Medtex International Corp. | DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-
2) (COLLOIDAL GOLD) – Zhuhau 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 |
For more information and inquiries, kindly contact the FDA-Center for Device Regulation, Radiation Health, and Research through email 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.2020-2183