PMA P890064S022
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S022
- Product code
- MAQ
- Decision date
- 2010-05-17
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- CHANGE IN SUPPLIER FOR THE REAGENT IN THE DEVICE.
Current openFDA PMA Record#
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S022
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2010-05-17
- Decision code
- OK30
- Date received
- 2010-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN SUPPLIER FOR THE REAGENT IN THE DEVICE.