PMA P920048S026
- Device
- TLiIQ QCette
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S026
- Product code
- LKV
- Decision date
- 2024-10-23
- Classification
- Clinical Toxicology
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- to add a new supplier for the printed TLiIQ QCette strip for TLiIQ QCette. The TLiIQ QCette is a component of the Rapid fFN for the TLiIQ System
Current openFDA PMA Record#
- Device
- TLiIQ QCette
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S026
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2024-10-23
- Decision code
- OK30
- Date received
- 2024-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a new supplier for the printed TLiIQ QCette strip for TLiIQ QCette. The TLiIQ QCette is a component of the Rapid fFN for the TLiIQ System