PCR ELEVA 1.2

FDA 510(k)

FDA Class 2 ·Radiology

CoLink PCR Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

PHILIPS PCR-ACE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

QM300 PCR ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)

FDA 510(k)

FDA Class 2 ·Radiology

Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

B. anthracis Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Variola virus Real-Time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ARTUS INFL A/B RG RT-PCR KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Sentosa SA201 HSV 1/2 Qualitative PCR Test

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology