PMA P220006S002
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S002
- Product code
- QUL
- Decision date
- 2023-08-29
- Classification
- Medical Genetics
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.
Current openFDA PMA Record#
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S002
- Product code
- QUL
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Decision date
- 2023-08-29
- Decision code
- OK30
- Date received
- 2023-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.