Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBEAG ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAGII ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAG ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM ASSAY

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Alinity i AFP Reagent Kit

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Free PSA Reagent Kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Total PSA Reagent Kit