Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR COMPONENTS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas TaqMan HBV Test v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cobas HPV Test

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV-GT Assay

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard®

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Shield

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD