Biotope, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Biotope, Inc. makes
Biotope, Inc. manufactures in vitro diagnostic devices under the ECLIPSE ICA series, including analyzers and single-use test cartridges for measuring triglycerides, glucose, digoxin, thyroid-stimulating hormone (TSH), cholesterol, and blood urea nitrogen (BUN). These devices are designed for point-of-care or near-patient testing in clinical settings.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II in vitro diagnostics. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Eclipse Ica Triglycerides Ref K905601
Regimes: 510(k) Registry: 510(k)Eclipse Ica Glucose Ref K905144
Regimes: 510(k) Registry: 510(k)Eclipse Ica Digoxin Ref K905719
Regimes: 510(k) Registry: 510(k)Eclipse Ica Tsh Ref K910256
Regimes: 510(k) Registry: 510(k)Eclipse Ica Analyzer Ref K910302
Regimes: 510(k) Registry: 510(k)Eclipse Ica Cholesterol Ref K905145
Regimes: 510(k) Registry: 510(k)Eclipse Ica Bun Ref K905602
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotope, Inc. have in the registry?
The registry currently lists 7 devices for Biotope, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotope, Inc.'s devices?
Among its 7 most recently registered devices, Biotope, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Biotope, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Biotope, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotope, Inc. in the registry?
The most recently registered devices listed for Biotope, Inc. include ECLIPSE ICA TRIGLYCERIDES, ECLIPSE ICA GLUCOSE, ECLIPSE ICA DIGOXIN and ECLIPSE ICA TSH.