Bartels Immunodiagnostic Supplies, Inc.
United StatesFDA applicant, unverified
- Devices
- 35
What Bartels Immunodiagnostic Supplies, Inc. makes
The company produces diagnostic reagents and cell cultures for microbiological testing, including HEp-2 and human fibroblast cells for cytopathology assays, fluorescent antibody kits for detecting cytomegalovirus and chlamydia, viral transport media, and cytotoxicity assay reagents for Clostridium species. It also supplies phosphate-buffered saline with divalent cations, monoclonal antibodies labeled with FITC for chlamydia detection, and primary cell cultures like rabbit kidney and McCoy cells for laboratory use.
These products are classified under FDA’s Class I and Class II regulatory categories, with some requiring 510(k) clearance. The company’s items are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the US.
Catalogue
Search and filter all 35 devicesFrequently asked questions
How many devices does Bartels Immunodiagnostic Supplies, Inc. have in the registry?
The registry currently lists 35 devices for Bartels Immunodiagnostic Supplies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bartels Immunodiagnostic Supplies, Inc.'s devices?
Among its 35 most recently registered devices, Bartels Immunodiagnostic Supplies, Inc. has devices listed in FDA 510(k) (35 devices).
What risk classes do Bartels Immunodiagnostic Supplies, Inc.'s devices fall under?
Among its 35 most recently registered devices, the classes recorded for Bartels Immunodiagnostic Supplies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bartels Immunodiagnostic Supplies, Inc. in the registry?
The most recently registered devices listed for Bartels Immunodiagnostic Supplies, Inc. include HEP-2 CELLS, HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN, CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI and CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT.