PMA P020022

Device: VERSANT HCV RNA 3.0 ASSAY (BDNA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P020022
Supplement: S010
Product code: MZP
Decision date: 2013-12-23
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.

Current openFDA PMA Record

Device: VERSANT HCV RNA 3.0 ASSAY (BDNA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P020022
Supplement: S010
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2013-12-23
Decision code: APPR
Date received: 2011-12-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.