The Aptima® Auto Detect Kit. This kit is to be used with the Leader® HC+ Luminometer and the Tigris® instrument system.

The Aptima® Specimen Transfer Kit consists of transfer tubes containing specimen transport medium (STM) and is intended for use with Aptima® assays. Refer to the appropriate product package insert for the indicated uses of the Aptima® Specimen Transfer Kit for each Hologic product.

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.

The Aptima® System Fluid Preservative Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the System Fluid Preservative Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual.

The Aptima® Assay Fluids Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the Assay Fluids Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual.

Aptima® HPV Assay, 250 test, box 1 of 2 (2°C to 8°C box).

Aptima® HPV Assay, 250 test, box 2 of 2 (15°C to 30°C box).

Aptima® HPV Assay Calibrators Kit.

Aptima® HPV Assay Controls Kit.

The Aptima® Auto Detect Kit is for use on the Panther® System.

The Aptima® Assay Fluids Kit is for use on the Panther® System.

Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°C box).

Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 2 of 2 (15°C to 30°C box).

Aptima® GT HPV 16 18/45 Genotype Assay Calibrators Kit.

Aptima® HPV Assay, 100 test, box 2 of 2 (15°C to 30°C box).

Aptima® HPV Assay, 100 test, box 1 of 2 (2°C to 8°C box).

9G INTRODUCER LOCALIZATION SET (-OB MODEL) FOR ATEC0914-20MR

9G INTRODUCER LOCALIZATION SET (-OB MODEL) FOR ATEC0914-20MR

ImageChecker® computer-aided detection is a software application intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed.

SecurMark for ATEC Stainless steel biopsy site marker

SecurMark for ATEC Stainless steel biopsy site marker

SecurMark for Eviva Stainless steel biopsy site marker

SecurMark for Eviva Stainless steel biopsy site marker

SecurMark for Eviva Stainless steel biopsy site marker

SecurMark MRI Biopsy site marker

SecurMark MRI Biopsy site marker

SecurMark MRI Biopsy site marker

SecurMark Ultrasound Biopsy site marker

SecurMark Ultrasound Biopsy site marker

SecurMark Ultrasound Biopsy site marker