PMA P890064S004
- Device
- HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S004
- Product code
- MAQ
- Decision date
- 1996-08-28
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR CHANGES IN MANUFACTURING METHODS AND PROCEDURES, AND LABELING MODIFICATIONS
Current openFDA PMA Record#
- Device
- HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S004
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 1996-08-28
- Decision code
- APPR
- Date received
- 1996-05-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN MANUFACTURING METHODS AND PROCEDURES, AND LABELING MODIFICATIONS