Pharmacia Deutschland GmbH
GermanyFDA applicant, unverified
- Devices
- 10
What Pharmacia Deutschland GmbH makes
Pharmacia Deutschland GmbH manufactures in vitro diagnostic tests for detecting specific antibodies, including cardiolipin IgA, IgM, and IgG antibodies, B2 glycoprotein I antibodies (IgA, IgG, IgM), SSDNA antibodies, histone antibodies, and PR3-ANCA. These tests are designed for laboratory use to aid in the diagnosis of autoimmune and connective tissue disorders.
The portfolio consists of Class II in vitro diagnostic devices, all of which are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Varelisa Ssdna Antibodies, Model 14896 Ref K040811
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Varelisa Histone Antibodies, Model 16496 Ref K040810
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Varelisa PR3 Anca, Model Number 17748/17796 Ref K041043
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pharmacia Deutschland GmbH have in the registry?
The registry currently lists 10 devices for Pharmacia Deutschland GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pharmacia Deutschland GmbH's devices?
Among its 10 most recently registered devices, Pharmacia Deutschland GmbH has devices listed in FDA 510(k) (10 devices).
What risk classes do Pharmacia Deutschland GmbH's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Pharmacia Deutschland GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pharmacia Deutschland GmbH in the registry?
The most recently registered devices listed for Pharmacia Deutschland GmbH include VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796, VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696, VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 and VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096.