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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