Miles, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
What Miles, Inc. makes
Miles, Inc. manufactures automated in-vitro diagnostic systems and associated assay methods for clinical chemistry and immunology. These include systems like the Technicon Immuno 1, H*2, and H*3 for biochemical and immunoassay testing, as well as the Technison Axon and Opera systems for laboratory analysis. Specific assays cover measurements such as creatinine, CK-MB, folate, and amylase, designed for use with their proprietary hardware platforms.
The company’s devices are regulated under the US FDA’s 510(k) pathway, with products classified as Class I and Class II in-vitro diagnostics. These systems are listed in the FDA’s 510(k) database, reflecting their compliance with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Miles, Inc. have in the registry?
The registry currently lists 11 devices for Miles, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miles, Inc.'s devices?
Among its 11 most recently registered devices, Miles, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Miles, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Miles, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Miles, Inc. in the registry?
The most recently registered devices listed for Miles, Inc. include IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM, TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM, TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) and FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM.