PMA P890064S018

Device: DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S018
Product code: MAQ
Decision date: 2006-04-28
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL FOR A CHANGE IN THE SAMPLE CONVERSION PROTOCOL FOR SPECIMENS COLLECTED IN PRESERVCYT SOLUTION. THE MAXIMUM NUMBER OF SPECIMENS THAT CAN BE PROCESSED AT ONE TIME WAS INCREASED FROM 20 TO 36 SPECIMENS.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S018
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2006-04-28
Decision code: APPR
Date received: 2006-03-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN THE SAMPLE CONVERSION PROTOCOL FOR SPECIMENS COLLECTED IN PRESERVCYT SOLUTION. THE MAXIMUM NUMBER OF SPECIMENS THAT CAN BE PROCESSED AT ONE TIME WAS INCREASED FROM 20 TO 36 SPECIMENS.