PMA P050045S003

Device: TOP2A FISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S003
Product code: NXG
Decision date: 2011-11-10
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Approval order statement: ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE.

Current openFDA PMA Record#

Device: TOP2A FISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S003
Product code: NXG
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Decision date: 2011-11-10
Decision code: OK30
Date received: 2011-10-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE.