cobas HPV

FDA Premarket Approval P190028 S005

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

An update to the hazard information on the product labeling for kits on the cobas 6800/8800 systems.

Devicecobas HPV
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantRoche Molecular Systems, Inc.
Date Received2021-05-18
Decision Date2021-06-02
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P190028Original Filing
S005 2021-05-18 Special (immediate Track)
S004 2020-11-13 30-day Notice
S003 2020-09-17 Special (immediate Track)
S002 2020-07-27 30-day Notice
S001 2020-04-10 30-day Notice

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