Seppim, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Seppim, Inc. makes
Seppim, Inc. manufactures the Triglyceride Reagent-Trinder-GPO, a diagnostic reagent used for measuring triglyceride levels in blood samples via enzymatic colorimetric methods.
The Triglyceride Reagent-Trinder-GPO is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Triglyceride Reagent-Trinder-Gpo Ref K832460
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Seppim, Inc., initiated on 2013-09-04. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 4 Sep 2013 Z-0178-2014 Class II Terminated Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Frequently asked questions
How many devices does Seppim, Inc. have in the registry?
The registry currently lists 1 device for Seppim, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seppim, Inc.'s devices?
Among its 1 most recently registered device, Seppim, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Seppim, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Seppim, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Seppim, Inc.?
FDA recall records list 1 recall initiated by Seppim, Inc., the most recent initiated on 4 Sep 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Seppim, Inc. in the registry?
The most recently registered devices listed for Seppim, Inc. include TRIGLYCERIDE REAGENT-TRINDER-GPO.