HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)

FDA premarket approval P890064/S006 · decided 1999-03-17

Approval details

PMA number

P890064

Supplement

S006

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)

Generic name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant

Qiagen Gaithersburg, Inc.

Date received

1997-09-30

Decision date

1999-03-17

Days to decision

533 days

Decision code

APPR

Product code

MAQ

Advisory committee

Microbiology

Expedited review

No

Location

Germantown, MD

Statement

Approval for chaning the solid phase on which the RNA:DNA hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (Digene Cervical Sampler), addition of the Digene Sample Conversion Kit,a nd the addition of new assay performance characteristics. The device, as modified, will be marketed under the trade name Digene HPV Test Using Hybrid Capture(R) II Technology (HCII HPV) witht he following indications: The Digene HPV Test using