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 |
BIOTECNICA DIAGNOSTICS INC |
HIGHTOP SARS-CoV-2 IgM/IgG ANTIBODY RAPID TEST | SC-COVID19-2020-082 |
RAPID |
2 |
SCIENTIFIC BIOTECH SPECIALTIES INC |
DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgG ANTIBODY
(MAGNETIC PARTICLE CLIA) |
SC-COVID19-2021-003 |
RAPID |
3 |
SCIENTIFIC BIOTECH SPECIALTIES INC |
DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgM ANTIBODY (MAGNETIC PARTICLE CLIA)
(Specimens: Human Serum) |
SC-COVID19-2021-070 |
RAPID |
4 |
NINGBO UNIMED PHILIPPINES INC |
SARS-CoV-2 Antibody Test (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY) | SC-COVID19-2020-176 |
RAPID |
5 |
INDOPLAS PHILIPPINES, INC |
Novel coronavirus (2019-nCoV) antigen detection kit
(colloidal gold method) |
SC-COVID19-2021-012 |
ANTIGEN |
6 |
MDX NETHERLANDS DIAGNOSTICS, INC |
SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) | SC-COVID19-2020-667 |
ANTIGEN |
7 |
ULIVACCINES, INC |
AFIAS COVID-19 Ab | SC-COVID19-2020-315 |
RAPID |
8 |
MARSMAN DRYSDALE MEDICAL PRODUCTS, INC. |
ACON SARS-CoV-2 IgG/IgM Rapid Test | SC-COVID19-2020-499 |
RAPID |
9 |
WORLDWIDELINK TRADING CORPORATION |
ichroma COVID-19 Ag | SC-COVID19-2020-704 |
ANTIGEN |
10 |
WORLDWIDELINK TRADING CORPORATION |
STANDARD™ Q COVID-19 IgG/IgM DUO TEST | SC-COVID19-2020-304 |
RAPID |
11 |
WORLDWIDELINK TRADING CORPORATION |
STANDARD Q COVID-19 IgM/IgG COMBO KIT | SC-COVID19-2020-326 |
RAPID |
12 |
WORLDWIDELINK TRADING CORPORATION |
STANDARD™ Q COVID-19 Ag TEST | SC-COVID19-2020-314 |
ANTIGEN |
13 |
TRULABORATORIES CORPORATION |
2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) | SC-COVID19-2020-277 |
RAPID |
14 |
JUNIPER 3 PROCUREMENT CORPORATION |
A Rapid IgM-IgG Combined Antibody Test Kit for
SARS-CoV-2 (ICA) |
SC-COVID19-2020-809 |
RAPID |
15 |
JUNIPER 3 PROCUREMENT CORPORATION |
Novel Coronavirus(2019-nCoV) Antibody (IgG/IgM)
Combined Test Kit (Immunochromatographic method) |
SC-C0VID19-2020-538 |
RAPID |
16 |
JUNIPER 3 PROCUREMENT CORPORATION |
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit
(PCR-Fluorescence Probing) |
SC-COVID19-2020-572 |
RT-PCR |
17 |
MDX NETHERLANDS DIAGNOSTICS, INC. |
Anti-SARS-CoV-2 S Protein Antibody Test Card – | SC-COVID19-2021-092 |
RAPID |
18 |
MDX NETHERLANDS DIAGNOSTICS, INC. |
Neutralizing Antibody of SARS-CoV-2 Test (Fluorescence Immunochromatographic Assay) | SC-COVID19-2021-091 |
RAPID |
19 |
MDX NETHERLANDS DIAGNOSTICS, INC. |
COVID-19 Neutralizing Antibody Detection Kit | SC-COVID19-2021-105 |
RAPID |
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.