PMA P980024S006

Device: PATHVYSION HER-2 DNA PROBE KIT
Applicant: Abbott Molecular, Inc.
PMA number: P980024
Supplement: S006
Product code: MVD
Decision date: 2012-02-27
Classification: System, Test, Her-2/neu, Nucleic Acid Or Serum
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Approval order statement: APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE PATHVYSION HER-2 DNA PROBE KIT, INCLUDING CHANGES ASSOCIATED WITH FISH PROBE RESTRICTION ENZYMEDIGESTED GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR A260 ABSORBANCE READINGS, ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE AND REVISION TO MANUFACTURING PROCEDURE DOCUMENT FOR LSI HER-2/NEU AMINATED DNA.

Current openFDA PMA Record#

Device: PATHVYSION HER-2 DNA PROBE KIT
Applicant: Abbott Molecular, Inc.
PMA number: P980024
Supplement: S006
Product code: MVD
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Decision date: 2012-02-27
Decision code: APPR
Date received: 2011-10-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE PATHVYSION HER-2 DNA PROBE KIT, INCLUDING CHANGES ASSOCIATED WITH FISH PROBE RESTRICTION ENZYMEDIGESTED GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR A260 ABSORBANCE READINGS, ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE AND REVISION TO MANUFACTURING PROCEDURE DOCUMENT FOR LSI HER-2/NEU AMINATED DNA.