Miles Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 159
What Miles Laboratories, Inc. makes
Miles Laboratories, Inc. manufactures diagnostic reagent strips and kits for urinalysis, including test strips for urinalysis, as well as specialized reagent strips for measuring enzymes like CK and ALT/SGPT. The company also produces calibrators for total bilirubin, digital data printers for laboratory results, and slide stainers for hematology samples. Additionally, it offers qualitative tests for drugs such as primidone and digoxin, alongside control sera for test validation.
The company’s products are regulated under FDA pathways, including 510(k) clearances for Class I and Class II devices and PMA authorizations for Class III devices. These diagnostic tools are listed in the FDA’s 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 159 devicesShowing 1-50 of 159
Frequently asked questions
How many devices does Miles Laboratories, Inc. have in the registry?
The registry currently lists 159 devices for Miles Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miles Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Miles Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Miles Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Miles Laboratories, 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 Laboratories, Inc. in the registry?
The most recently registered devices listed for Miles Laboratories, Inc. include AMES TDA TM PRIMIDONE TEST, OPTIMATE DIGOXIN TEST, LAB-TEK FTA-ABS KIT and HEMA-TEK II SLIDE STAINER.