ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

FDA 510(k)

FDA Class 2 ·Hematology

System, Multipurpose For In Vitro Coagulation Studies

FDA classification

FDA Class 2 ·System, Multipurpose For In Vitro Coagulation Studies

DIGI-PRO TENS MODEL WL-2203 AND WL-2205

FDA 510(k)

FDA Class 2 ·Neurology

IPS 99 ONE AND IPS 99 CERAM

FDA 510(k)

FDA Class 2 ·Dental

SIGMA REAGENT SYSTEM NO. 885

FDA 510(k)

FDA Class 2 ·Hematology

WOUNDCHEK Bacterial Status

FDA 510(k)

FDA Class 2 ·Microbiology

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

FDA 510(k)

FDA Class 2 ·Immunology

AURA TEK FDP

FDA 510(k)

FDA Class 2 ·Immunology

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

FDA 510(k)

FDA Class 2 ·Immunology

NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT

FDA 510(k)

FDA Class 2 ·Immunology

ALERE PBP2A SA/CONS CULTURE COLONY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

FDA 510(k)

FDA Class 2 ·Microbiology

MRSA-SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

BARD AND BTA TEST

FDA 510(k)

FDA Class 2 ·Immunology

MASTALEX -MRSA, MODEL RST501

FDA 510(k)

FDA Class 2 ·Microbiology

BARD BTA TRAK TEST

FDA 510(k)

FDA Class 2 ·Immunology