Intl. Bioclinical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Intl. Bioclinical, Inc. makes
Intl. Bioclinical, Inc. manufactures diagnostic reagent sets and calibrator kits for measuring serum levels of medications, including digoxin and valproic acid, as well as an analyzer system for automated immunoassay testing. Their products include the INNOFLUOR™ Digoxin and Valproic Acid reagent sets, calibrator sets, and the ABC FP Analyzer for progesterone testing via enzyme immunoassay (EIA).
The company’s portfolio includes Class I and Class II devices, with several products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the manufacturer is based in the United States.
Catalogue
Innofluor(Tm) Digitoxin Reagent Set Ref K913187
Regimes: 510(k) Registry: 510(k)Innofluor Valproic Acid Calibrator Set Ref K911466
Regimes: 510(k) Registry: 510(k)Abc Fp Analyzer Ref K883533
Regimes: 510(k) Registry: 510(k)Progesterone System By Eia Ref K864156
Regimes: 510(k) Registry: 510(k)Innofluor(Tm) Valproic Acid Reagent Set Ref K911688
Regimes: 510(k) Registry: 510(k)Innofluor(Tm) Digitoxin Calibrator Set Ref K913186
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intl. Bioclinical, Inc. have in the registry?
The registry currently lists 6 devices for Intl. Bioclinical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Bioclinical, Inc.'s devices?
Among its 6 most recently registered devices, Intl. Bioclinical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Intl. Bioclinical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Intl. Bioclinical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intl. Bioclinical, Inc. in the registry?
The most recently registered devices listed for Intl. Bioclinical, Inc. include INNOFLUOR(TM) DIGITOXIN REAGENT SET, INNOFLUOR VALPROIC ACID CALIBRATOR SET, ABC FP ANALYZER and PROGESTERONE SYSTEM BY EIA.