Ortho Clinical Diagnostics100 Indigo Creek Dr Rochester Ny 14626 5101 Pma Numberp100001 Supplement Numbers017 Date Received09 30 2022 Decision Date01 24 2023 Product Code Lom Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Ortho Clinical Diagnostics100 Indigo Creek Dr Rochester Ny 14626 5101 Pma Numberp100001 Supplement Numbers017 Date Received09 30 2022 Decision Date01 24 2023 Product Code Lom Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P100001S017 ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2023-01-24