Epitope Diagnostics, Inc.
United Statesfrom the FDA registration address FDA FEI 3004185580
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Epitope Diagnostics, Inc. makes
Epitope Diagnostics, Inc. manufactures fecal occult blood in vitro diagnostic (IVD) reagents, including the EDI™ CARE™ and CARE FECAL OCCULT BLOOD TEST, MODEL KT313.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Epitope Diagnostics, Inc. is based in the US.
Catalogue
- Registry: GUDID
Care Fecal Occult Blood Test, Model KT313 Ref K051806
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3004185580
- DUNS number
- 144563058
- Address
- 17034 Camino San Bernardo, SAN DIEGO, CA, 92127
- Website
- www.epitopediagnostics.com/
- [email protected]
- Phone
- 858 693-7877
FDA recalls
FDA recall records list 1 recall initiated by Epitope Diagnostics, Inc., initiated on 2020-10-01. By recorded status: 1 ongoing. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 1 Oct 2020 Z-0426-2021 Class II Open since 2020 The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
From the company website
Epitope Diagnostics Inc., a certified medical device manufacturer, specializes in niche immunoassays, offering ELISA kits, rapid tests, and antibodies.
Frequently asked questions
How many devices does Epitope Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Epitope Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epitope Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Epitope Diagnostics, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Epitope Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Epitope Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Epitope Diagnostics, Inc.?
FDA recall records list 1 recall initiated by Epitope Diagnostics, Inc., the most recent initiated on 2020-10-01. 1 of them is recorded as ongoing. 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 Epitope Diagnostics, Inc. in the registry?
The most recently registered devices listed for Epitope Diagnostics, Inc. include EDI™ CARE™ KT-313 and CARE FECAL OCCULT BLOOD TEST, MODEL KT313.