PMA P190024S001
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S001
- Product code
- QKF
- Decision date
- 2020-08-14
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Approval order statement
- Approval for expanding the indications for use to add the cobas® 6800/8800 Systems (cobas® HPV) test to identify HPV positive patients.
Current openFDA PMA Record#
- Device
- CINtec PLUS Cytology
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190024
- Supplement
- S001
- Product code
- QKF
- Generic name
- Immunocytochemistry assay, p16/Ki-67
- Decision date
- 2020-08-14
- Decision code
- APPR
- Date received
- 2020-04-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanding the indications for use to add the cobas® 6800/8800 Systems (cobas® HPV) test to identify HPV positive patients.