Dade Intl., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 31
What Dade Intl., Inc. makes
Dade International, Inc. manufactures diagnostic reagents, calibrators, and test systems for laboratory use, including paramax reagents for ammonia, salicylate, and cholesterol, as well as immunoassay kits like the Stratus CK-MB and Troponin-I test system. The company also produces dried microbiology panels for Gram-negative and Gram-positive bacterial identification and Flex reagent cartridges for drugs such as gentamicin and acetaminophen. Additionally, it supplies platelet function analyzers with disposable test cartridges and candidate product combinations for quality control in clinical laboratories.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with some products authorised via 510(k) clearances and others through PMA submissions. These products are listed in the FDA’s regulatory databases and are intended for in vitro diagnostic use in clinical settings. The company operates from the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Dade Intl., Inc. have in the registry?
The registry currently lists 31 devices for Dade Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dade Intl., Inc.'s devices?
Among its 31 most recently registered devices, Dade Intl., Inc. has devices listed in FDA 510(k) (30 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dade Intl., Inc.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Dade Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dade Intl., Inc. in the registry?
The most recently registered devices listed for Dade Intl., Inc. include PARAMAX SALICYLATE REAGENT, ACA PLUS FT4 CALIBRATOR, PARAMAX AMMONIA AND AMMONIA BLANK REAGENT and DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/.