CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

FDA premarket approval P080014 · decided 2009-03-12

Approval details

PMA number

P080014

Trade name

CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

Generic name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant

Hologic, Inc.

Date received

2008-04-28

Decision date

2009-03-12

Days to decision

318 days

Decision code

APWD

Product code

MAQ

Advisory committee

Microbiology

Expedited review

No

Location

Marlborough, MA

Statement

APPROVAL FOR THE CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT. CERVISTA HPV HR INDICATIONS FOR USE: THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNAFROM 14 HIGH-RISK- HUMAN PAPILLOMAVIRUS (HPV) TYPES (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,59, 66, AND 68) IN CERVICAL SPECIMENS. THE CERVISTA HPV HR TEST CANNOT DETERMINE THESPECIFIC HPV TYPE PRESENT.THE CERVISTA HPV HR TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FORDETECTION OF S

510(k) clearances by this applicant