PMA P890064S014

Device: DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S014
Product code: MAQ
Decision date: 2004-05-04
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S014
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2004-05-04
Decision code: APPR
Date received: 2003-11-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).