PMA P890064S017

Device: DIGENE HYBRID CAPTURE HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S017
Product code: MAQ
Decision date: 2004-12-14
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL FOR PACKAGING QUALITY CONTROL MATERIAL IN THE HYBRID CAPTURE 2 HPV DNA TEST KITS THAT WAS PREVIOUSLY PROVIDED UNDER A SEPARATE PRODUCT CODE, AS WELL AS THE ADDITION OF AN UPPER LIMIT FOR THE HPV POSITIVE CONTROL TEST VALUES.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S017
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2004-12-14
Decision code: APPR
Date received: 2004-11-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR PACKAGING QUALITY CONTROL MATERIAL IN THE HYBRID CAPTURE 2 HPV DNA TEST KITS THAT WAS PREVIOUSLY PROVIDED UNDER A SEPARATE PRODUCT CODE, AS WELL AS THE ADDITION OF AN UPPER LIMIT FOR THE HPV POSITIVE CONTROL TEST VALUES.