PMA P980024S014
- Device
- PATH VYSION HER-2 DNA PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S014
- Product code
- MVD
- Decision date
- 2016-07-13
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).
Current openFDA PMA Record#
- Device
- PATH VYSION HER-2 DNA PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S014
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2016-07-13
- Decision code
- OK30
- Date received
- 2016-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).