PMA P110012S002
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S002
- Product code
- OWE
- Decision date
- 2012-12-26
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S002
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2012-12-26
- Decision code
- OK30
- Date received
- 2012-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.