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

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

ZIKV Detect 2.0 IgM Capture ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

FDA 510(k)

FDA Class 2 ·Microbiology