Detection

Taiwan has extraordinary biotechnology capabilities in research and development. Academia Sinica, Taiwan’s National Health Research Institutes (NHRIs) and National Defense Medical Center and companies dedicate to development COVID-19 testing kits and equipment.

Equipment/Materials

Inspection Equipment

General Biologicals Corporation

Automatic Nucleic Acid Extraction System

TAIWAN ADVANCED NANOTECH INC.

Automated Extraction Instruments


 CE/FDA 

BluSense Diagnostics

BluBox

 -CE

Applied BioCode

BMB system

510K/FDA

TCI GENE INC.

Automated virus scanner operated by robotic arms

-CE/ FDA: in process
-TFDA: April 9, 2020

CHINA SURGICAL DRESSINGS CENTER CO., LTD.

Swabs

CE、FDA

Zinexts Life Science Corp

Nucleic acid isolation system

CE

GeneReach Biotechnology Corp.

Automatic Nucleic Acid Extraction System/Nucleic Acid Analyzer


 CE-IVD 

Quark Biosciences, Inc.

dqPCR Analysis System

ISO 9001

WINNOZ TECHNOLOGY, INC.

COVID-19 Rapid Test Bundle

CE and ISO 13485 in 2020

YOHO Medical Enterprise Co., Ltd

Swabs

CE、FDA

Biotech

Extraction Reagents

General Biologicals Corporation

GB Extraction Kit

CE (self-declaration)

GeneReach Biotechnology Corp.

Nucleic Acid Extraction Reagents


CE-IVD 

Abnova Corporation.

Viral RNA Purification Kit (Pre-filled)

Certification In process

Zinexts Life Science Corp

Nucleic Acid Extraction Reagents

CE

TAIWAN ADVANCED NANOTECH INC.

Reagent Kit-DNA/RNA extractions


CE/FDA 

Test Kits

UNITED BIOPHARMA, INC.

UBI® SARS CoV 2 ELISA

EUA FDA CE In process

BluSense Diagnostics

ViroTrack, Rapid Test

CE In process

Excelsior Bio-System

ALERT SARS-CoV-2
Antibody Rapid Test

EUA/CE certification In process

General Biologicals Corporation

GB COVID-19 IgG / IgM Rapid Test
GB SARS-CoV-2 Real-Time RT-PCR – 4PCO002E (3 target genes)
-GB SARS-CoV-2 Real-Time RT-PCR – 4PCO042E (2 target genes)

Certification In process

LEADGENE BIOMEDICAL, INC.

Leadgene® SARS/SARS-CoV-2 Antigen Rapid Test

Certification In process

Medigen Vaccine Biologics.

MVC SARS-CoV-2 qPCR Kit

CE

GeneReach Biotechnology Corp.

SARS CoV-2 (orf 1ab)
premix reagent


 -TFDA
-CE-IVD in process 

Medigen Biotechnology Corp.

SARS-CoV-2 IgG / IgM Rapid Test Kit
ExProbe SARS-CoV-2 Testing Kit

-FDA/EUA notification
-CE、EUA in application

Abnova Corporation.

COVID-19 Human IgM IgG Rapid Test

CE In process
-Apply for EUA certification
-RUO

LEADGENE BIOMEDICAL, INC.

Leadgene® SARS-CoV-2
Antibody Rapid Test

Certification In process

AEP Alliance (Taiwan)
(AnTaimmu BioMed Co., Ltd, EirGenix, Inc. and Panion & BF Biotech)

COVID-19 Antigen
Rapid Test (Vstrip)

Certification In process

Kimforest Enterprise Co.Ltd

-P/N: KF2019CoV01
SARS-CoV-2 Detection kit V1
-P/N: KF2019CoV02
SARS-CoV-2 Detection kit V2

-CE
-TFDA EUA: Expected to get in May
-US EUA: Expected to get in JUN

Applied BioCode

BioCode® SARS-CoV-2 Assay Kit

EUA authorize

Quark Biosciences, Inc.

DigiChip™ SARS-CoV-2 Assay

ISO 9001

About TAITRA

TAITRA is Taiwan's foremost nonprofit trade promoting organization. Sponsored by the government and industry organizations, TAITRA assists enterprises to expand their global reach. Headquartered in Taipei, TAITRA operates 5 local offices as well as 63 branches worldwide.

⦿ UPDATE: Taiwan to donate COVID-19 rapid antibody test kits to Honduras ⦿ UPDATE: FDA Grants Emergency Use Authorization for PreciGenome, PlexBio Coronavirus Tests