PMA P160037S002

Device: Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S002
Product code: MAQ
Decision date: 2019-05-13
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for use of a modified SurePath vial for collection of specimens to be tested with the Onclarity HPV Assay, and the automated transfer of pre- and post- cytology aliquots using the BD Totalys Multiprocessor for testing with the BD Onclarity Assay.

Current openFDA PMA Record#

Device: Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S002
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2019-05-13
Decision code: APPR
Date received: 2019-02-26
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for use of a modified SurePath vial for collection of specimens to be tested with the Onclarity HPV Assay, and the automated transfer of pre- and post- cytology aliquots using the BD Totalys Multiprocessor for testing with the BD Onclarity Assay.