VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P880009 S003

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

DeviceVIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantQIAGEN, INC.
Date Received1989-09-18
Decision Date1990-02-01
PMAP880009
SupplementS003
Product CodeMAQ
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN, INC. 1201 Clopper Road gaithersburg, MD 20878

Supplemental Filings

Supplement NumberDateSupplement Type
P880009Original Filing
S005 1991-10-18 Normal 180 Day Track
S004 1991-05-24 Normal 180 Day Track
S003 1989-09-18 Normal 180 Day Track
S002 1989-06-16 Normal 180 Day Track
S001 1989-04-04 Normal 180 Day Track

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