PMA P890064S039

Device

digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Applicant

Qiagen Gaithersburg, Inc.

PMA number

P890064

Supplement

S039

Product code

MAQ

Decision date

2018-03-16

Classification

Kit, Dna Detection, Human Papillomavirus

Generic name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Approval order statement

Modification of QC testing for a critical subcomponent of the test.

Summary

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