Miles Laboratories, Inc.
United StatesFDA 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 devicesAmes Tda Phenobarbital Test Ref K802255
Regimes: 510(k) Registry: 510(k)Seralute Tsh (Ria) Ref K771767
Regimes: 510(k) Registry: 510(k)Seralute Ref K760572
Regimes: 510(k) Registry: 510(k)Seralyzer Uric Acid Reagent Strips - Ref K800848
Regimes: 510(k) Registry: 510(k)Hemagglutination Inhibition Test Ref K772095
Regimes: 510(k) Registry: 510(k)Ames Tda Amikacin Control Serum Ref K803107
Regimes: 510(k) Registry: 510(k)Tissue-Tek Iii Mini-Rapid Processor Ref K801427
Regimes: 510(k) Registry: 510(k)Glucometer Ii Improved Reflectance Photometer Ref K861303
Regimes: 510(k) Registry: 510(k)Biostator Glucose Controller Ref P800032
Regimes: PMA Registry: PMA
Showing 151-159 of 159