
Company profileCompany history
VEDALAB is a privately owned French company, founded in 1991
VEDALAB is devoted to the development, production and marketing of in vitro immunodiagnostic rapid tests. As a market leader, VEDALAB focuses on international expansion by forming long-term partnerships with reliable and trustworthy distributors worldwide. Continually expanding its already broad range of products, VEDALAB is as of today the biggest real manufacturer of rapid tests in Europe.
VEDALAB’s headquarters, its research and development, manufacturing and marketing departments are all located in a modern, well-equipped and expanding (4 500 m²) ISO certified plant in the beautiful Normandy town of Alençon. VEDALAB employs about 50 people all of whom are dedicated to the design, development, manufacture or promotion of a very wide range of innovative reagents and instruments, including the use of patented technologies.
Throughout its years of development, VEDALAB has acquired incomparable research experience ranging from initial antibody screening to the creation of its own manufacturing equipment. Such unparalleled experience has made VEDALAB a reference of quality in the world of immunodiagnostics.
History
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2022
CE marking of Calprotectin rapid test in faeces sample (Calprotectin'Alert) for home use.
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2021
New quantitative rapid tests for reader use: NT-proBNP and anti-SARS-CoV-2 spike antibody tests. CE marking of COVID-19-CHECK-1 Antigen in nasal swab sample for home use and CE marking of rotavirus+adenovirus rapid test in faeces sample (ROTADENO-Screen) for home use.
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2020
Covid-19-Check-1 immunochromatographic rapid test for the detection of IgM and IgG antibodies to SARS-CoV-2 virus in human whole blood, plasma or serum samples.
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2019
New quantitative rapid tests for reader use: C peptide. CE marking of Streptococcus A rapid test in throat sample (Strepa'lert) and hCG pregnancy test in whole blood sample (Babycheck-1 WB) for home use.
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2018
New quantitative rapid tests for reader use: HbA1c and Hb Total. CE marking of Gluten rapid test (Gluten'Alarm) for home use.
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2017
New product development: PSA Free quantitative rapid test. Qualitative rapid test for the detection of Alanine Transaminase (ALT) and Aspartate transaminase (AST).
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2016
New quantitative rapid tests for reader use: CA 15-3, CA 19-9, CALPROTECTIN, CORTISOL, TRANSFERRIN. Obtention of CE marking of Ebola rapid test (Ezyscreen). Launch of Trio TOXIN A+B+GDH qualitative rapid test.
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2015
Extension of the company facility (300 m²). Launch of the new Easyreader+® quantitative rapid tests reader New product development: T3 quantitative rapid test for reader use. Legionella rapid test. Streptococcus pneumoniae rapid test.
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2014
New product development: CYSTATIN C quantitative rapid test for Easy Reader use. HS-PROLACTIN quantitative rapid test for Easy Reader use. ULTRA-TSH quantitative rapid test for Easy Reader use.
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2013
Extension of the company facility (700 m²). New product development: FABP rapid test. HS-INSULIN quantitative rapid test for Easy Reader use. Procalcitonin quantitative rapid test for Easy Reader use. T4 quantitative rapid test for Easy Reader use.
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2012
New product development: Giardia lamblia, helicobacter pylori antigen (in feces), insulin qualitative rapid tests. Insulin quantitative rapid test for Easy reader use. FSH quantitative rapid test for Easy reader use. LH quantitative rapid test for Easy reader use. HS-CRP quantitative rapid test for Easy reader use. HS-TSH quantitative rapid test for Easy reader use.
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2011
Celebration of the 20th anniversary of the company's creation. CE marking of Lyme (Tik'Alert®) for home use. CE marking of IgE (Allergy-Check®) for home use. Insulin quantitative rapid test for Easy Reader use. FSH quantitative rapid test for Easy Reader use.
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2010
CE marking of Ferritin (Ferri-Check®) for home use. CE marking of helicobacter pylori (Pylori-Screen®) for home use. CE marking of TSH (Thyro-Check®) for home use. CA-125 quantitative rapid test for Easy Reader use. Micro-albumin quantitative rapid test for Easy Reader use. Quality system accreditation (CMDCAS) in Canada : ISO 13485 (2003).
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2009
FOB quantitative rapid test for Easy reader use. EN ISO 9001 (2008) and EN ISO 13485 (2003) certification obtained from MDC GmbH notified body.
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2008
CK-MB quantitative rapid test for Easy reader use. hCG quantitative rapid test for Easy reader use. CE marking of HEM (Poly-Check®) for home use.
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2007
IgE quantitative rapid test for Easy reader use. New product development: Influenza A and B, C.d. Toxin B, Lyme IgG and IgM. CE marking of PSA (Prosta-Check®) for home use. CEA quantitative rapid test for Easy reader use. Prolactin quantitative rapid test for Easy reader use. AFP quantitative rapid test for Easy reader use.
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2006
Ferritin quantitative rapid test for Easy reader use. Myoglobin quantitative rapid test for Easy reader use. New product development: Chagas qualitative rapid test. Departure of Milovan Stankov. Patent litigation settlement.
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2005
NF EN ISO 13485 (2004) certification obtained from LNE/GMED (French notified body). Launch of VEDA.LAB rapid test reader (Easy Reader). PSA semi-quantitative and quantitative rapid test for Easy reader use. Troponin I quantitative rapid test for Easy reader use. TSH quantitative rapid test for Easy reader use. Uricheck biochemistry strips.
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2004
Quality system management approved on the basis of ISO 9001 (2000) and ISO 13485 52001) standards.
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2003
Full application of European IVD 98/79/CE requirements. GMP (EN 46001) certification renewal of the QA system by G-Med (French notified body). New products development. Launch of a rapid test reader optimized for PSA rapid test for quantitative results reading.
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2002
Automation of production (2nd stage). Compliance with CE requirements. new products development.
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2001
Celebration of the 10th anniversary of the company's creation. CE marking of Babycheck® and Evidence® pregnancy tests. Construction of the third phase of the GMP facility. New products development.
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2000
Application of European IVD 98/79/CE. Extension of the QA certificate as per GMP (EN46001).
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1999
QA system certified by the French QA association (AFAQ). New products developed: Adenovirus, Rotavirus, RSV.
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1998
Automation of production (1st stage).
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1997
Construction (extension) of the second phase of the GMP facility.
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1996
New VEDA.LAB products developed in-house (cardiac markers, drugs of abuse, TB and syphilis) were launched on the international market.
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1995
Set-up of the Quality Assurance system (QA) in compliance with ISO 9001 standards. Development of veterinary rapid tests (FIV, FeLV).
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1994
Construction (extension) of the first phase of a new GMP facility.
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1993
FDA approval of pregnancy test in USA (510K). Export of rapid tests to India, China, Russia and Latin America.
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1992
Product launch on the US market. Development of other fertility tests (LH, FSH) and infectious disease rapid tests (Chlamydia and Strep A).
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1991
Foundation of the company by Milovan Stankov and Raphael Donati. Launch of the Babycheck® pregnancy test in France and Europe.