PMA P890064S007

Device: DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S007
Product code: MAQ
Decision date: 2000-03-16
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for removal of the reagent component "Probe A" and Indication number 1. The device, as modified, will be marketed under the trade name Digene High-Risk HPV DNA Test using Hybrid Capture.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S007
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2000-03-16
Decision code: APPR
Date received: 2000-02-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for removal of the reagent component "Probe A" and Indication number 1. The device, as modified, will be marketed under the trade name Digene High-Risk HPV DNA Test using Hybrid Capture.