S.A., a privately owned company
founded in 1991, by Dr Donati and Mr Stankov,specialises in R&D
and the production of rapid immunochromatographic tests and kits.
We are focusing
on international expansion through the formation of strategic alliances
and partnerships with distributors worldwide. We are one of the
largest European certified companies involved in rapid medical diagnostic
tests and kits.
R&D and manufacturing resources are located in an ultramodern
ISO 9001- and ISO 13485 -accredited facility on the outskirts of
the nice French city of ALENCON.
occupies 3000 m2 of modern R&D and manufacturing facilities
and employs about 50 people who focus on designing, developing,
producing and marketing a wide range of innovative products with
has targeted its research and development resources on technological
applications in immunology, primarily in the area of in-vitro diagnostics,
and, thanks to the company's people, entrepreneurial spirit and
a tremendous amount of hard work, VEDA.LAB has
managed to achieve exemplary growth in the industry. VEDA.LAB
is now a reference in the field of rapid diagnostics worldwide.
s major developments are as follows :
||Lyme CE mark for home use
IgE CE mark for home use
INSULIN quantitative test for the rapid test reader
FSH quantitative test for the rapid test reader
Ferritin CE mark for home use
H. Pylori CE mark for home use
TSH CE mark for home use
CA-125 quantitative test for the rapid test reader
Microalbumin quantitative test for the rapid test reader
Quality system accreditation (CMDCAS) in Canada : ISO 13485 : 2003.
||FOB quantitative test for the rapid test reader.
EN ISO 9001 (2008) - EN ISO 13485 (2003) Certification obtained from MDC GmbH notified body.
CK-MB quantitative test for the rapid test reader.
hCG quantitative test for the rapid test reader.
HEM CE mark for home use (POLY-CHECK ®).
IgE quantitative test for the rapid test reader.
New product development (Influenza A and B, C.d.Toxin
B, Lyme IgG and IgM)
PSA CE mark for home use.
CEA quantitative test for the rapid test reader.
PROLACTIN quantitative test for the rapid test reader.
AFP quantitative test for the rapid test reader.
FERRITIN quantitative test for the rapid test reader.
MYOGLOBIN quantitative test for the rapid test reader.
New product development (Chagas).
Departure of Milovan STANKOV.
Patent litigation settlement.
NF EN ISO 13485 : 2004 certification obtained from LNE/GMED
(French notified body).
VEDA.LAB rapid test reader (EASY READER®),
PSA semi-quantitative and quantitative determination for
the rapid test reader
TROPONIN I quantitative determination for the rapid test
TSH quantitative determination for the rapid test reader
URICHECK biochemistry strips.
Quality system management approved on the basis of ISO
9001 : 2000 and ISO 13485 : 2001 standards.
New products developed.
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 optimised for PSA rapid
test quantitative results reading.
Automation of production (2nd stage).
Compliance with CE requirements.
New products developed
Celebration of the 10th anniversary of the company's
CE marking of "Baby Check" and "Evidence"
Construction of the third phase of the GMP facility.
New products developed
of European IV 98/79CE.
Extension of the QA certificate as per GMP (EN46001).
System certified by the French QA association (AFAQ)
New products developed (ADENO, ROTA, RSV).
Automation of production (1st stage).
(extension) of the second phase of the GMP facility.
VEDA.LAB products developed in-house (cardiac markers,
DOA, TB and Syphilis) were launched on the international
of the Quality Assurance system (QA) in compliance with
ISO 9001 standards.
Development of veterinary rapid tests (FEV, FELV).
of the first phase of a new GMP facility
approval of pregnancy test in USA (510 k)
Export of rapid tests to India, China, Russia and Latin
launch on the US market
Development of other fertility (LH, FSH) and infectious
disease rapid tests (Chlamydia and Strep A).
of the company by Mr STANKOV and Dr DONATI
Launch of the Baby Check pregnancy test in FRANCE and