PMA P890064S013
- Device
- HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S013
- Product code
- MAQ
- Decision date
- 2003-11-07
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR: 1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE; THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME. AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP. 2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS THAT HAVE RESULTS WITHIN THIS RESULT ZONE, FOR SPECIMENS COLLECTED IN PRESERVCYT TRANSPORT MEDIUM. THIS EQUIVOCAL RESULT ZONE HAS BEEN ESTABLISHED TO BE >=1.0 AND <+ 2.5 RLU/CO. 3)_ REMOVAL OF THE EQUIVOCAL RESULT ZONE FROM SPECIMENS COLLECTED IN THE DIGENE SPECIMEN TRANSPORT MEDIUM.
Current openFDA PMA Record#
- Device
- HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S013
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2003-11-07
- Decision code
- APPR
- Date received
- 2003-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR: 1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE; THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME. AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP. 2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS THAT HAVE RESULTS WITHIN THIS RESULT ZONE, FOR SPECIMENS COLLECTED IN PRESERVCYT TRANSPORT MEDIUM. THIS EQUIVOCAL RESULT ZONE HAS BEEN ESTABLISHED TO BE >=1.0 AND