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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.

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