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 101-150 of 159

What Miles Laboratories, Inc. makes

Catalogue159

Seralyzer Glucose Calibrators(Low&High) Ref K801665

Test For Ketone In Urine(Acetoacetic Ac Ref K801270

Ames Tda Tobramycin Test Ref K810941

Ames Sera-Pak Glucose Reagent Ref K811392

Seralyzer Creatinine Reagent Strips Ref K820075

Glucometer M Blood Gulcose Meter Ref K855202

Ames Tda/Gentgmicin Ref K790584

Seralyzer Iii Blood Chemistry Analyzer Ref K872120

Seralyzer Drug Assay Control Serum Ref K833977

Cliniria T-3 Uptake Test Ref K781180

Ames Tda Gentamicin Test Ref K810942

Tissue-Tek Iii Accu-Cut Rotary Microtome Ref K812558

Ames Tda Valproic Acid Test Ref K830789

Seralyzer Aris Phenytoin Reagent Strips Ref K842092

Ames Tda Quinidine Test Ref K812753

Sera-Tek Mycoplasma Antibody Test Ref K832132

Serayzer Alt/Sgpt Reagent Strips Ref K832791

Glucolet Automatic Lancing Device For Obt. Blood Ref K855203

Seralyzer Multicomponent Calibrators Ref K832046

Sera-Tek Thyroglobulin Antibody Test Ref K865020

Amhs Blood Analy. Triglyceoides Reag. Ki Ref K771004

Tissue-Tek Immunohistology Kit Lysozzm Ref K842470

Visidex Ii Reagent Strips Ref K852747

Cliniria Total T-4 (Ria) Test Ref K781181

Glucofacts Data Management System Ref K861844

Clinitek Auto 2000 Reagent Cassette (Leukocytes) Ref K873304

Diastix Reagent Strips For Urinalysis Ref K831600

Ames Tda Amikacin Ref K801130

Accraassay Rid Kits Ref K761311

Clinitek 10 Semi-Auto Urinalysis Sys Ref K842238

Ames Sera-Pak Uric Acid Reagent Kit Ref K802724

Ames Tda Theophylline Test Ref K810943

Clinifacts 10 Data Management System Ref K844907

Ames Tda Netilmicin Test & Serum Ref K832088

Labeling Change For Cutter Pureflo Plus Iv Filter Ref K880605

Ames Tda Theophyl-Line Test Ref K800646

Modified Saltex Reagent Strips Ref K870214

Cutter Pureflo Plus Iv Filter Ref K872634

Clini-Tek Auto 2000 Reflectance Spectr Ref K841041

Seralyzer Hemoglobin Test Module Ref K822045

Optimate Digoxin Test Ref K841582

Sera Aris Pheno Reag Strip, Test Mod Cal & Clt Ref K852946

Tissue-Tek Iii Microject Disp. Blade Sys Ref K801426

Ames Tda Carbamazepine Test Ref K811952

Slide, Lab-Tek Covered Micro Ref K760278

Lab-Tek Anacult Anaerobic Culture Chambe Ref K800899

Seralyzer Hemoglobin Calibrators Ref K822046

Visidex Ii Reagent Strips Ref K831989

Chromatography Tubes Ref K790581

Glucometer Qc Blood Meter, Ames Gluco System Print Ref K871835