PMA P090008S023

Device

VITROS HBeAg Assays

Applicant

ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

PMA number

P090008

Supplement

S023

Product code

MZO 

Decision date

2023-01-24

Generic name

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus