PMA P020022S011

Device: VERSANT HCV RNA 3.0 ASSAY (BDNA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P020022
Supplement: S011
Product code: MZP
Decision date: 2012-10-24
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE IN MICROPLATE COATING EQUIPMENT FOR A COMPONENT, AND A CHANGE TO ADD AN INCOMING FUNCTIONAL TEST FOR A SUPPLIER COMPONENT.

Current openFDA PMA Record

Device: VERSANT HCV RNA 3.0 ASSAY (BDNA)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P020022
Supplement: S011
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2012-10-24
Decision code: OK30
Date received: 2012-09-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN MICROPLATE COATING EQUIPMENT FOR A COMPONENT, AND A CHANGE TO ADD AN INCOMING FUNCTIONAL TEST FOR A SUPPLIER COMPONENT.