PMA P890064S020

Device: DIGENE HYBRID CAPTURE2
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S020
Product code: MAQ
Decision date: 2009-08-12
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT TURNER BIOSYSTEMS IN SUNNYVALE, CALIFORNIA, TO MANUFACTURE THE DML 3000¿ MICROPLATE LUMINOMETER WHICH IS INTENDED FOR USE WITH THE HYBRID CAPTURE 2 HIGH RISK HPV DNA TEST AND HYBRID CAPTURE 2 HPV DNA TEST.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE2
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S020
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2009-08-12
Decision code: APPR
Date received: 2008-01-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT TURNER BIOSYSTEMS IN SUNNYVALE, CALIFORNIA, TO MANUFACTURE THE DML 3000¿ MICROPLATE LUMINOMETER WHICH IS INTENDED FOR USE WITH THE HYBRID CAPTURE 2 HIGH RISK HPV DNA TEST AND HYBRID CAPTURE 2 HPV DNA TEST.