Syva Co., Dade Behring, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 19
What Syva Co., Dade Behring, Inc. makes
Syva Co., Dade Behring, Inc. manufactures immunoassay systems for measuring drugs and toxins in biological samples, including the EMIT 2000 and EMIT II Plus platforms. These systems detect substances like thyroxine, digoxin, opiates, cannabinoids, and ethyl alcohol, alongside calibrators for assay accuracy. The portfolio also covers modifications for specific drug assays, such as phencyclidine, propoxyphene, methadone, and methaqualone, as well as theophylline and tobramycin.
The company’s devices are classified under FDA Class II and Class U, with regulatory submissions recorded in the FDA 510(k) database. These products are intended for in vitro diagnostic use in clinical settings and are listed under U.S. jurisdiction. The manufacturer operates from the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Syva Co., Dade Behring, Inc. have in the registry?
The registry currently lists 19 devices for Syva Co., Dade Behring, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syva Co., Dade Behring, Inc.'s devices?
Among its 19 most recently registered devices, Syva Co., Dade Behring, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Syva Co., Dade Behring, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Syva Co., Dade Behring, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syva Co., Dade Behring, Inc. in the registry?
The most recently registered devices listed for Syva Co., Dade Behring, Inc. include SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS, EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229, EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 and MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229.