BIOFACT

History

BIOFACT that provides various products and services
by improving and newly creating the original biotechnology

2022
- 04
  
  Acquired the ISO 9001:2015 Certification for medical device
2020
- 05
  
  Certified as a small business with technical innovation
  (INNO-BIZ)
- 05
  
  Certified as a venture company(rating agency: Korea Technology Finance Corporation)
2019
- 02
  
  Certified as Grade A for the evaluation of
  accuracy in genetic tests
2018
- 12
  
  Acquired the ISO 13485:2016 Certification for medical device
- 02
  
  Certified as Grade A for the evaluation of
  accuracy in genetic tests
2017
- 02
  
  Certified as Grade A for the evaluation of
  accuracy in genetic tests
2016
- 06
  
  Certified as Grade A for the evaluation of
  accuracy in genetic tests
- 01
  
  Acquired the ISO 13485:2012 Certification for medical device
2014
- 09
  
  Certified as a venture company(rating agency: Korea SMEs and Startups Agency)
2013
- 07
  
  Got permission as a medical device manufacturer (Daejeon Regional Korea Food & Drug Administration)
- 06
  
  Changed the corporate name to BIOFACT Co., Ltd
- 04
  
  Registered the plant
- 01
  
  Registered the genetic testing agency(Korea Centers for Disease Control and Prevention)
2012
- 11
  
  Approved the corporate-affiliated research institute(Korea Industrial Technology Association)
- 07
  
  Founded Seoul Branch
- 06
  
  Founded

BIOFACT

Certificate

We will make continuous efforts for the best quality.

BIOFACT Co., Ltd is maintaining the highest-level of product & service qualities by reflecting the international standard screening to its own product/service production system, and also making efforts to systematically establish/operate
the production system through the thorough quality control system.

Certificate & ISO 13485: 2016

ISO13485 : 2016
Certificate of genetic testing agency
Certificate of venture company
Certificate of corporate affiliated research institute
License of manufacturer for medical devices for in vitro diagnosis
Certificate of
Inno-Biz

Patents

Magnetic particle separation unit
HPV detection set
96well magnetic particle separation unit
Cylindrocarpon destructans
Method of distinguishing Cylindrocarpon destructans

* Scroll left and right

Name of invention,Patent manager,Right,Registration/Application number
Name of invention	Patent manager	Right	Registration/Application number
Magnetic particle separation unit	BIOFACT Co., Ltd	Registration	No.10-1905136 (2018.09.28)
Oligonucleotide set for the detection of HPV	BIOFACT Co., Ltd	Registration	No.10-2012-0100648 (2019.02.27)
96well magnetic particle separation unit for plate & PCR tube	BIOFACT Co., Ltd	Registration	No.10-1942097 (2019.01.18)
Primer set for the detection of strain in paenibacillus with antibacterial activity toward Cylindrocarpon destructans, and main method of detection in paenibacillus using this	BIOFACT Co., Ltd	Registration	No.10-1925039 (2018.11.28)
Primer set for the detection of Burkholderia pyrrocinia with antibacterial activity toward Cylindrocarpon destructans, and method of discerning the density of Burkholderia pyrrocinia	BIOFACT Co., Ltd	Registration	No.10-1925039 (2018.11.28)