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.

Biotech

Test Kits

UNITED BIOPHARMA, INC.

UBI® SARS CoV 2 ELISA

-FDA EUA

BluSense Diagnostics

ViroTrack, Rapid Test

CE In process

Excelsior Bio-System

ALERT SARS-CoV-2
Antibody Rapid Test

 TFDA EUA Approval (2020.05.29)
CE Certification(2020.07.13)
US FDA Notification Status (2020.08.27)
US FDA Submission (EUA202680)
(2020.09.02)

General Biologicals Corporation

GB SARS-CoV-2 Real-Time RT-PCR – 4PCO002E (3 target genes)
-GB SARS-CoV-2 Real-Time RT-PCR – 4PCO042E (2 target genes)

 -CE(2020.04.23)
-India CDSCO(2020.05.25)
-Australia ARTG
-TFDA (2020.06.10)

LEADGENE BIOMEDICAL, INC.

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

Certification In process

General Biologicals Corporation

GB SARS-CoV-2 Ab ELISA

Medigen Biotechnology Corp.

ExProbe SARS-CoV-2 Testing Kit

-FDA EUA Approved (2020.06.10)
-CE (2020.05.08)
-TFDA EUA approved (2020.07.24)

GeneReach Biotechnology Corp.

SARS CoV-2 (orf 1ab)
premix reagent


 -TFDA
-CE-IVD in process 

Agnitio Science & Technology

Rapid Test

TAIWAN ADVANCE BIO-PHARMACEUTICAL INC.

COVID-19 Antibody Rapid Test Kit

ENIMMUNE CORPORATION

Speedy COVID-19 Ag Rapid Test

 CE (2020.12.18)
ISO 13485

COLD SPRING BIOTECH CORP.

Rapid Test

TONYAR BIOTECH. INC

Rapid Test

TFDA(2020.08.24)

iXensor Co., LTD.

The PixoTest® POCT COVID-19 Antigen Test


RUO CE Certification in Process

Abnova Corporation

COVID-19 Viral Antigen Rapid Test

TFDA (2021.01)
CE-IVD (2020.12.23)

Agnitio Science & Technology

BioIC SARS-CoV2 IgG/IgM Detection Kit

CE

Eternal Materials Co., Ltd.

COVIDual COVID-19 IgM/IgG Rapid Test

 CE IVD: (2020.07.06)
TFDA/FDA/EUA: in process

SMOBIO Technology, Inc.

RT-qPCR and dNTPs

Medigen Biotechnology Corp.

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

-FDA EUA approved (2020.09.01)
-CE(2020.05.08)

Abnova Corporation.

COVID-19 Human IgM IgG Rapid Test

RUO CE-IVD

Abnova Corporation.

COVID-19 Human IgM IgG ELISA

RUO CE-IVD

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)

 TFDA(2020.08.27)

Kimforest Enterprise Co.Ltd

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

 -US FDA EUA (2020.09.21)
-Philippines FDA
-CE (2020.05)
-TFDA (2020.06.30)

Applied BioCode

BioCode® SARS-CoV-2 Assay Kit

EUA authorize

Quark Biosciences, Inc.

DigiChip™ SARS-CoV-2 Assay

ISO 9001

Formosa Biomedical Technology Corp.

Rapid Test

TAIWAN CARBON NANO TECHNOLOGY CORPORATION

SARS-COV-2 Antigen Rapid Test Kit

CE

ALLBIO SCIENCE, INC.

COVID19 IgG & IgM Rapid Test
COVID19 IgG & IgM Antibody
Detection Kit (Colloidal Gold Method)
For in vitro diagnosis

CE
TFDA(2020.09.01)

TRISON TECHNOLOGY INTEGRATION CORPORATION

Rapid Test

 TFDA(2020.07.27)

TAIDOC TECHNOLOGY CORPORATION

Antigen Rapid Test


 CE (2020.08.28)
GMP(2020.09.15)

PlexBio Co., Ltd.

IntelliPlex SARS CoV-2 Detection Kit

CE-IVD(2020.04) 、FDA EUA(2020.06)

GeneReach Biotechnology Corp.

POCKIT™ Central SARS-CoV-2 (orf 1ab) Premix Reagent


 -FDA-EUA notified (2020.05)
-CE-IVD (2020.04.17)
-TFDA-EUA(2020.04.06) 

Applied BioCode

BioCode® SARS-CoV-2 Assay Kit

-EUA Authorized (2020.06.16)

Applied BioCode

BioCode® Cov-2 Flu Plus

-EUA submitted (2020.12.25)

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 

GeneReach Biotechnology Corp.

taco™ Preloaded DNA/RNA Extraction Set


-CE IVD(2018.02)
-TFDA

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

-TFDA (2020.04.09)
-FDA Listing(2020.06.11)
-CE(2020.10.29)

CHINA SURGICAL DRESSINGS CENTER CO., LTD.

Swabs

CE、FDA

Delta Electronics, Inc.

Automated Nucleic Acid Analysis System G1

BRAIN NAVI BIOTECHNOLOGY CO., LTD

The Autonomous Nasal Swab Collecting Robot

TFDA EUA

TAIGEN BIOSCIENCE CORPORATION

LabTurbo AIO SP-qPCR System

TFDA(2020.05.11)
FDA Listing
CE

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

DELBio, Inc
(A member of the Delta Group)

Dagene G1
Automated Nucleic Acid Analysis System
& Dagene G SARS-CoV-2 Test Assay

TFDA (EUA) (2020.12.2)

YOHO Medical Enterprise Co., Ltd

Swabs

CE、FDA

GeneReach Biotechnology Corp.

Platform: POCKIT™ Central Nucleic Acid Analyzer


 -FDA-EUA notified(2020.05)
-CE-IVD (2019.05.24)
-TFDA (2019.10

LifeOS Genomics Corp

LifeOS QLociTM Automated Multiplex Digital PCR System

CHUNG FU TECHNICAL DEVELOPMENT CO., LTD.

Biological Safety Cabinet

Disposable Medical Isolation Gown and Material Manufacturer List

The coronavirus pandemic has created a global shortage of personal protective equipment (PPEs), including disposable medical gowns and isolation gown material. There are several types of medical gowns, such as isolation gowns (P1, Level 1 equivalent) and protective non-woven coveralls (P2/P3, Level3/4 equivalent). Taiwanese suppliers of disposable medical gowns/isolation gown material are leaders in the market, benefiting from Taiwan’s stable, high-quality supply chain.

All of the raw materials we use to manufacture disposable medical gowns are produced in Taiwan with specific respect to the United Nations Sustainable Development Goals (UN SDGs). Additionally, all product quality, deliveries and customer services are fully supported by our supply chain. Furthermore, all materials and finished products are tested and certified by the Taiwan Textile Research Institute (TTRI), which is ISO-12705 approved and accredited by the Taiwan Accreditation Foundation (TAF) (0491).

Taiwan has been praised for its highly effective and successful COVID-19 response, which includes early screening of flights, the tracking of individual cases and strong support of the PPE supply chain.
The swift actions taken by the Ministry of Economic Affairs (i.e., Bureau of Foreign Trade, TAITRA, Industrial Development Bureau) and the Ministry of Health and Welfare to unite the Taiwan textile and apparel industry has created effective and efficient production lines for PPEs, including high-quality face masks, disposable medical gowns, isolation gown material and protective coveralls.

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: May 20_Taiwan Confronts Sudden COVID-19 Outbreak with Technological Governance Ingenuity and Extraordinary Civic Cooperation