Company History
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QMS certification received
-Received from the Ministry of Health and Welfare (Taiwan)
Zhejiang BiOptic has received Class I medical device certification
-Class I medical device certification April
The Core Products Are Successfully Registered and Listed in FDA
-Can be sold as medical equipment in the United States
-Qsep Series Bio-Fragment Analyzers & Cartridges
-Qampmini Thermal Cycler
-Accessories & Consumables for Instrument
Qsep Ultra Prototype Released
-Integrated PCR and capillary electrophoresis analyzer
-Automatic analysis after sampling
Second Oversea Factory Built
2nd Oversea Factory - Hangzhou, Zhejiang, CN
Qexp-MDx Direct SARS-CoV-2 Detection System obtain EU CE-IVD certification
Qexp-MDx Direct SARS-CoV-2 Detection System obtain EU CE-IVD certification
20th Pharmaceutical Technology & Research Award- Golden Award
Awarded by Industrial Development Bureau, Ministry of Economic Affairs & Taiwan Food and Drug Administration, Ministry of Health and Welfare
28th Taiwan Small and Medium Enterprises Innovation Award
Awarded by Small and Medium Enterprise Administration, Ministry of Economic Affairs
BiOptic Inc. Emerging Stock
Stock Symbol:6850
BiOptic Inc. Public Listing
Stock Symbol:6850
Qsep1-Lite Commercialized
-Replace the slab gel
-Simple mode software
-All-in-One step solution
Taipei Biotech Awards
Awarded by Taipei City Government, R.O.C.
Qexp-MDx APOE Genotyping Kit
Commercialized
-RUO only
-No need for nucleotide extraction, start PCR after simple lysis
-Multiplex PCR in one tube
Office & Production Line Expansion
Molecular Diagnostic Kits R&D Initaited
Qsep400 Commercialized
TFDA Class I Medical Device Certified
GMP Certified
Qsep1 Commercialized
-professional portable capillary electrophoresis system
-flexible sample capacity
-Higher sensitivity for analyzing diverse samples such as cfDNA
Oversea Factory Built & Qampmini and some accaccessaries launched
1st Oversea Factory - Changzhou, Jiangsu, CN
Q3- Qair Pump Commercialized
Q4- Qamp mini, PCR Reagents Commercialized
ODM Cooperation Agreement
Contract Manufacturing for ProZyme, Inc.
Qsep1 R&D initiated
Qsep1 Functional Prototype R&D Initiated
USA Branch Office Built
Qsep100 Commercialized
Best of Industrial Development Award
CE/FCC Granted
First Prototype Released
Qsep100 Bio-Fragment Analyzer Functional Prototype
BiOptic R&D Initaited
R&D of Qsep100 Prototype
SBIR Granted
ISO 13485 Certified
OEM Cooperation Agreement
Contract Manufacturing for QIAGEN
BiOptic Inc. Founded
Contract Manufacturing for eGene, Inc.
