Manufacturer and distributor of in vitro diagnostics and laboratory devices for clinical laboratory diagnostics.
DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
2351 Wiener Neudorf (IZ NOE-Süd, Hondastraße Objekt M55), ÖsterreichNew on Amplifa
About DIALAB
DIALAB GmbH is an Austrian manufacturer and distributor of diagnostics and laboratory equipment headquartered in Wiener Neudorf south of Vienna. Founded in 1972 as a trading company for pipettes and scales in Vienna, the company began producing diagnostic reagents in the early 1990s. Today the product range covers clinical chemistry, immunoturbidimetry, ELISA tests, blood grouping and Rhesus typing, serology, coagulation, urine strips, drug and glucose tests as well as matching laboratory devices such as photometers, ELISA and coagulation instruments. The company supplies clinical laboratories and the blood donation sector in more than 100 countries and also offers OEM manufacturing, distributor training and regulatory support for CE marking. On more than 4000 m² of production space, around 50 employees manufacture using modern technology; the quality management system is certified to ISO 13485:2016 and the IVDR Regulation (EU) 2017/746.
- Site
- Wiener Neudorf
- Processes
- OEM manufacturing, Dealer training (Distributor Training), CE marking/Regulatory Support for IVD products
- Materials
- ELISA Assays, Blood Grouping Reagents, Clinical Chemistry
- Certificates
- ISO 13485:2016, IVDR (EU) 2017/746, Annex IX, Chapters I and III, EC Design Examination (IVDD 98/79/EC, Annex IV(4), List A), IVDR (EU) 2017/746, Annex IX Chap. I and III, EC Design Examination (IVDD 98/79/EC, List A)
- Founded
- 1972
- Employees
- ~50
- Industries
- In Vitro Diagnostics (IVD), Clinical Laboratory Diagnostics, Laboratory Equipment, Blood Donation/Blood Banking
- 01
Development and design verification of the IVD products
- 02
Production of diagnostic reagents
- 03
Manufacturing/integration of laboratory instruments
- 04
Quality assurance according to ISO 13485 and IVDR
- 05
CE marking
- 06
Distribution and distributor training
- 07
OEM manufacturing for partners
Product Groups and Processes
ELISA Assays
Enzyme immunoassays for the qualitative detection of hepatitis B, hepatitis C and HIV markers in human serum or plasma.
Blood Grouping Reagents
Monoclonal reagents for AB0 blood grouping and Rhesus typing (C,c,D,E,e).
Clinical Chemistry
Reagents for clinical-chemical and immunological routine analyses in laboratory analyzers.
Locations
Wiener Neudorf
ATHeadquarters and main production site
Products
Inside the production
Industries
Additional services
Quality
DIALAB maintains a quality management system certified to ISO 13485:2016 as well as a QM system according to Regulation (EU) 2017/746 (IVDR), Annex IX, Chapters I and III. List A products are verified through EC Design Examination certificates from TÜV SÜD and bqs. s.r.o.
| Evidence | Wiener Neudorf |
|---|---|
| ISO 13485:2016 | |
| IVDR (EU) 2017/746, Annex IX Chap. I and III | |
| EC Design Examination (IVDD 98/79/EC, List A) |
History
- 1972
Founded as a trading company for pipettes and scales headquartered in Vienna
- frühe 1990er
Start of production of diagnostic reagents
- 2005
Relocation of headquarters and main production site to Wiener Neudorf south of Vienna
- 2014
Expansion of headquarters to more than 4000 m² of modern production space