PMA P890064S025

Device: DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S025
Product code: MAQ
Decision date: 2011-03-29
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: CHANGES FOR DIGENE® HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE® HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST LOCATED IN GAITHERSBURG, MD.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S025
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2011-03-29
Decision code: OK30
Date received: 2011-02-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES FOR DIGENE® HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE® HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST LOCATED IN GAITHERSBURG, MD.