Boehringer Mannheim Italia SpA
Country not established
- Devices
- 3
What Boehringer Mannheim Italia SpA makes
Boehringer Mannheim Italia Spa manufactures diagnostic test strips for detecting human chorionic gonadotropin (hCG) in urine and serum, including the EVENT Test Strip HCG and EVATEST Strip. They also produce serum diluent reagents, such as the ACCUSTAT HCG Serum Diluent, used to prepare hCG samples for testing.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Event Test Strip Hcg Ref K935502
Regimes: 510(k) Registry: 510(k)Evatest Strip Ref K936013
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Boehringer Mannheim Italia Spa have in the registry?
The registry currently lists 3 devices for Boehringer Mannheim Italia Spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boehringer Mannheim Italia Spa's devices?
Among its 3 most recently registered devices, Boehringer Mannheim Italia Spa has devices listed in FDA 510(k) (3 devices).
What risk classes do Boehringer Mannheim Italia Spa's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Boehringer Mannheim Italia Spa's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boehringer Mannheim Italia Spa in the registry?
The most recently registered devices listed for Boehringer Mannheim Italia Spa include EVENT TEST STRIP HCG, EVATEST STRIP and ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT.