Calbiochem-Behring Corp.
United StatesFDA applicant, unverified
- Devices
- 41
What Calbiochem-Behring Corp. makes
The company produces diagnostic reagents and test kits for infectious disease screening, including rubella antibody assays, rheumatoid factor reference sera, and immunoglobin (IgM, IgA, IgE) reagent systems. It also supplies radioimmunoassay (RIA) systems for thyroid hormone testing, such as triiodothyronine, and cervical cancer screening kits like the CBC Pap Test. Additional offerings include reference standards for antistreptolysin O (ASO) testing and serological diagnostic reagents for autoimmune and infectious disease markers.
These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I or Class II. The company’s diagnostic reagents and test kits are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does Calbiochem-Behring Corp. have in the registry?
The registry currently lists 41 devices for Calbiochem-Behring Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calbiochem-Behring Corp.'s devices?
Among its 41 most recently registered devices, Calbiochem-Behring Corp. has devices listed in FDA 510(k) (41 devices).
What risk classes do Calbiochem-Behring Corp.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for Calbiochem-Behring Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calbiochem-Behring Corp. in the registry?
The most recently registered devices listed for Calbiochem-Behring Corp. include CALBIOCHEM-BEHRING RIA-COUNT, RUBELLA ANTIBODIES TEST REAGENTS, FIBRO-TEC TEST KIT and RAPI/TEX ASO STANDARD SERUM.