Seppim S.A.S.
Country not established
- Devices
- 5
What Seppim S.A.S. makes
Seppim S.A.S. manufactures clinical laboratory reagents and systems for biochemical analysis, including creatinine, phosphorus, uric acid, urea, HbA1c, glucose, triglycerides, and cholesterol test kits. Their portfolio also covers calibrator sets and automated analyzer systems like the ELITECH CLINICAL SYSTEMS ELICAL 2 and ELITROL 1/2 for routine and specialized blood chemistry testing.
The company’s products are regulated under FDA 510(k) clearance for Class I and Class II devices, indicating they fall under general and special controls for laboratory reagents and diagnostic systems. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech Clinical Ref K100547
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seppim S.A.S. have in the registry?
The registry currently lists 5 devices for Seppim S.A.S.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seppim S.A.S.'s devices?
Among its 5 most recently registered devices, Seppim S.A.S. has devices listed in FDA 510(k) (5 devices).
What risk classes do Seppim S.A.S.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Seppim S.A.S.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Seppim S.A.S. in the registry?
The most recently registered devices listed for Seppim S.A.S. include ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL, ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS, ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL and ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2.