PMA P140021S008

Device: Elecsys Anti-HCV II Test System
Applicant: Roche Diagnostics Operations, Inc.
PMA number: P140021
Supplement: S008
Product code: MZO
Decision date: 2017-08-10
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: Approval for 1) the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 411 immunoassay analyzer and 2) a modification to the proprietary device name.

Current openFDA PMA Record#

Device: Elecsys Anti-HCV II Test System
Applicant: Roche Diagnostics Operations, Inc.
PMA number: P140021
Supplement: S008
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2017-08-10
Decision code: APPR
Date received: 2017-03-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for 1) the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 411 immunoassay analyzer and 2) a modification to the proprietary device name.