PMA P890064S005

Device: HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S005
Product code: MAQ
Decision date: 1997-08-15
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA Assay.

Current openFDA PMA Record#

Device: HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S005
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 1997-08-15
Decision code: APPR
Date received: 1996-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA Assay.