BD Onclarity HPV Assay

FDA Premarket Approval P160037 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change in materials used in manufacture of critical assay component

DeviceBD Onclarity HPV Assay
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantBECTON, DICKINSON AND COMPANY
Date Received2020-02-21
Decision Date2020-03-19
PMAP160037
SupplementS006
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152

Supplemental Filings

Supplement NumberDateSupplement Type
P160037Original Filing
S006 2020-02-21 30-day Notice
S005
S004
S003 2019-08-21 Normal 180 Day Track No User Fee
S002 2019-02-26 Real-time Process
S001 2018-04-27 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00382904440893 P160037 000
00382904440879 P160037 000
00382904438371 P160037 000
00382904429676 P160037 000
00382904429577 P160037 000

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