PMA P890064S032
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S032
- Product code
- MAQ
- Decision date
- 2015-05-29
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN PENANG, MALAYSIA.
Current openFDA PMA Record#
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S032
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2015-05-29
- Decision code
- APPR
- Date received
- 2015-04-28
- 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 IN PENANG, MALAYSIA.