Innovacon, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000057104
- Devices
- 262
- Registrations
- EUDAMED
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
What Innovacon, Inc. makes
Innovacon, Inc. manufactures in vitro diagnostic devices, including the INNOVACON HCG UKTRA TEST DEVICE, INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE, and INNOVACON SPECTRUM II TEST CARD.
The company's devices are classified as Class II and listed in the FDA 510(k) registry. Innovacon, Inc. is based in the US.
Catalogue
Search and filter all 262 devicesShowing 1-50 of 262
Company details
- EUDAMED SRN
- US-MF-000057104
- EUDAMED status
- Active
- EUDAMED registered name
- Innovacon, Inc.
- EUDAMED abbreviated name
- Innovacon
- Registered address
- 9942, Mesa Rim Road, 92121, San Diego, United States
- [email protected]
- PRRC contact
- Irene Yasuda
FDA recalls
FDA recall records list 1 recall initiated by Innovacon, Inc., initiated on 2007-10-01. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 1 Oct 2007 Z-1118-2008 Unclassified (pre-2012) Terminated Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.
Frequently asked questions
How many devices does Innovacon, Inc. have in the registry?
The registry currently lists 262 devices for Innovacon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innovacon, Inc.'s devices?
Among its 50 most recently registered devices, Innovacon, Inc. has devices listed in EUDAMED (50 devices).
What risk classes do Innovacon, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Innovacon, Inc.'s devices are IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for Innovacon, Inc.?
FDA recall records list 1 recall initiated by Innovacon, Inc., the most recent initiated on 2007-10-01. 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 Innovacon, Inc. in the registry?
The most recently registered devices listed for Innovacon, Inc. include SureStep CE, SureStep, InstAlert and Strep A Rapid Test (Throat Swab).