FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VERIFY Assert Self-Contained Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

AXSYM REA ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)GRUNTZIG DILACA CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST