Aptima®

FDA UDI

Hologic, Inc.·15420045506800·Aptima® HCV Quant Dx Assay Calibrator.

Aptima®

FDA UDI

Hologic, Inc.·15420045506787·The Aptima® HCV Quant Dx assay is a real-time t...

Aptima

FDA UDI

Hologic, Inc.·15420045500235·

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

ID NOW™ Molecular System

FDA registration

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·3 products·🇺🇸 United States

410500 revogene Carba C

FDA registration

MERIDIAN BIOSCIENCE, INC.·2 products·🇺🇸 United States

Revogene Carba C

FDA registration

Meridian Bioscience Canada Inc.·2 products·🇨🇦 Canada

Panther Fusion AdV/hMPV/RV Assay Cartridges 96 Tests

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

Panther Fusion AdV/hMPV/RV Assay

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

BD BBL™ Columbia CNA Agar W/ 5% SB & Columbia CNA Agar W/ 5% SB

FDA UDI

BECTON, DICKINSON AND COMPANY·10382902998188·BD BBL™ Columbia CNA Agar with 5% Sheep B...

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard Stool DNA-Based Colorectal Cancer Screening Test

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·THE PATH VYSION HER-2 DNA PRODE KIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene Hybird Capture 2 (HC2) HPV DNA Test

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISI-I DNA Probe Cocktail

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY