Intracel Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Intracel Corp. makes
Intracel Corp. manufactures in vitro diagnostic tests for detecting and identifying infectious agents and monitoring immune cell counts. Their portfolio includes antigenemia assays for cytomegalovirus (CMV), ELISA tests for Legionella in urine, and respiratory pathogen screening kits. They also produce a CD4/CD8 cell monitoring kit for immune cell analysis.
The company’s diagnostic tests are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the 510(k) pathway. Their products are listed under the FDA’s regulatory framework and are based in the United States.
Catalogue
Bartels Cinakit Cmv Antigenemia Ref K982311
Regimes: 510(k) Registry: 510(k)Prima System - Old, Bartels Elisa - New Ref K990664
Regimes: 510(k) Registry: 510(k)Bartels Legionella Urinary Antigen Elisa Test Ref K991074
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Zymmune(Tm) CD4/CD8 Cell Monitoring Kit Ref K933878
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intracel Corp. have in the registry?
The registry currently lists 5 devices for Intracel Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intracel Corp.'s devices?
Among its 5 most recently registered devices, Intracel Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Intracel Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Intracel Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intracel Corp. in the registry?
The most recently registered devices listed for Intracel Corp. include BARTELS CINAKIT CMV ANTIGENEMIA, PRIMA SYSTEM - OLD, BARTELS ELISA - NEW, BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST and BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT.