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
CE-IVD (2020.12.23)
Agnitio Science & Technology
BioIC SARS-CoV2 IgG/IgM Detection Kit
Certification In process
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
-P/N: KF2019CoV02
SARS-CoV-2 Detection kit V2
-FDA EUA (2020.09.21)
-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
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.
Rapid Test
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
-CE/ FDA: in process
-TFDA: April 9, 2020
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 CORPORATIO
LabTurbo AIO SP-qPCR System
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.
Contact Us
Meet Taiwan Medical Services online
please contact sipro@taitra.org.tw
Meet suppliers online
please contact
e-member@taiwantrade.com
Source Taiwan Medical Products
Please contact mdd@taitra.org.tw
Find Taiwan Trade Center in your country/region (Taiwan Trade Center)
Useful Links
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.
