Development and manufacture of ELISA diagnostic kits for clinical laboratory diagnostics
AB Diagnostic Systems GmbH
Berlin (Berlin-Adlershof) · GermanyNew on Amplifa
About AB Diagnostic Systems
AB Diagnostic Systems GmbH is a biotechnology company founded in 2010 and based in Berlin-Adlershof. The company develops and manufactures in vitro diagnostics in accordance with Directive 98/79/EC. The abia product line comprises ELISA diagnostic kits for HIV, hepatitis B, C and E infections, COVID-19, prenatal diagnostics (TORCH), hormones (thyroid, fertility) and tumor markers. On a 2000 m² production area, up to one million microtiter plates can be manufactured per year; homogeneous batch sizes of up to 5,000 plates are possible. The company also offers OEM services for ELISA kits. Customers include clinical laboratories, blood banks and hospitals as well as international organizations such as UNOPS. According to the company, all tests are manufactured in Germany.
- Site
- Berlin
- Processes
- OEM services (ELISA kits), Manufacture of in vitro diagnostics in accordance with Directive 98/79/EC
- Certificates
- Directive 98/79/EC (IVD)
- Founded
- 2010
- Employees
- more than 30
- Industries
- Biotechnology, In vitro diagnostics (IVD), Medical technology, Clinical laboratory diagnostics, Blood banks, Hospitals
- 01
Development of diagnostic kits
- 02
Production of ELISA plates
- 03
Packaging and kitting
- 04
Distribution to laboratories, blood banks and hospitals
- 05
OEM services
Locations
Berlin-Adlershof
DEHeadquarters and production site
- Lot size
- Batches of up to 5,000 plates
Industries
Additional services
Reference customers
Quality
All tests are manufactured in accordance with European standards and Directive 98/79/EC on in vitro diagnostic devices.
| Evidence | Berlin-Adlershof |
|---|---|
| Directive 98/79/EC (IVD) |
History
- 2010
Foundation of AB Diagnostic Systems GmbH with the goal of advancing in vitro diagnostics.