PMA P890064S021

Device: DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S021
Product code: MAQ
Decision date: 2010-03-31
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S021
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2010-03-31
Decision code: APPR
Date received: 2010-02-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.