Genesis Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Genesis Labs, Inc. makes
Genesis Labs, Inc. manufactures reagent strips for diagnostic testing, including BIOSCAN and DIA SCREEN variants, designed for rapid in vitro analysis of biological samples. The BIOSCAN and DIA SCREEN reagent strips are intended for detecting specific substances in urine or serum, supporting point-of-care or clinical laboratory use. The 10-way DIA SCREEN variant provides expanded testing capabilities for multiple analytes simultaneously.
The company’s reagent strips are regulated under FDA’s 510(k) pathway, with devices classified as Class I or Class II depending on risk level. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Bioscan Reagent Strips Ref K943008
Regimes: 510(k) Registry: 510(k)Dia Screen Reagent Strips Ref K952971
Regimes: 510(k) Registry: 510(k)Dia Screen 10 Way Reagent Strips Ref K961375
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genesis Labs, Inc. have in the registry?
The registry currently lists 3 devices for Genesis Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genesis Labs, Inc.'s devices?
Among its 3 most recently registered devices, Genesis Labs, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Genesis Labs, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Genesis Labs, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genesis Labs, Inc. in the registry?
The most recently registered devices listed for Genesis Labs, Inc. include BIOSCAN REAGENT STRIPS, DIA SCREEN REAGENT STRIPS and DIA SCREEN 10 WAY REAGENT STRIPS.