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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue159

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Showing 51-100 of 159

What Miles Laboratories, Inc. makes

Catalogue159

Ames Lab Management System Ref K800724

Optimate Igg Test Ref K841816

Ames Tda/Tobramycin Ref K791435

Printer Ref K772099

Clinilab Automated Urinalysis System Ref K761306

Ames Tda Kanamycin Test-Control Serum Ref K832769

Ames Sera-Pak Hemoglobin Reagent Ref K803248

Tissue-Tek Iii V.I.P. Ref K771308

Pentex Lipoprotein Cholesterol Solu. Ref K800035

Ames Tda Tm Phenytoin Test Ref K811025

Seralyzer Ldh Reagent Strips, Calibr Ref K803019

Ames Tda Tm Phenobarbital Test Ref K810994

Gammacord Ii Calculator Interface Ref K761063

Seralyzer Aris Carbamazepine Strips/Modu/Cali/Cont Ref K863842

Tissue-Tek Iii Tissue Embedding Center Ref K801956

Clinistat Tda Series Ref K823112

Seralyzer System Ref K810639

Ames Tda Procainamide Test Ref K831400

Citoject Cartridge Syringe Ref K842006

Reagent Strips For Urinalysis Ref K790965

Seralyzer Ldh/Total Bilirubin/Triglycerides Strips Ref K870752

Micro-Bumintest Reagent Tablets Ref K874909

Clinifacts 200 Data Management System Ref K861778

Ames Tda Ethosuximide Test Ref K823801

Seralyzer Glucose (Hk) Reagent Strips, Module, Cali. Ref K864530

9-Way Urine Test With Ascorbic Ref K771755

Seralyzer Potassium Reagent Strips, Test Module, & Ref K844955

Seralyzer Blood Urea Nitrogen(Bun) Ref K801269

Fluorostat Fluorometer Ref K822701

Sera-Pak Total Protein Reagent Ref K802742

Lab-Tek Jembec G.C. Culture System Ref K811382

Seralyzer Triglycerides Reagent Strips Ref K832684

Lab-Tek Ana Test Kit Ref K792184

Seralyzer Glucose Reagent Strips Ref K801663

Ames Rialyze - Uptake Chrom. Tubes Ref K800170

Ames T-3 Uptake Strip Test Ref K772088

Rialyze Hpl (Ria) Ref K770659

Accudex Reagent Strips Ref K821247

Pentex Bovine Albumin 30% Solution Ref K800943

Optimate Iga Test Ref K841815

Seralyzer Glucose Test Module Ref K801664

Ames T-4 Strip Test Ref K772014

Ames Sera-Pak Albumin Reagent Kit Ref K803237

Ames Sera-Pak Cholesterol Reagent Kit Ref K802743

Ames Tda Gentamicin Test Ref K821669

Q-Line Ltc Ref K813580

Glucostix Reagent Strips & Glucometer Reflect-Phot Ref K851703

Redi-Disc Hemoglobin Gel Tube Kit Ref K780163

Amwa Tda Theophylline Test Ref K831514

Filter, Particulate Arresting Ref K760481