hc2 HPV DNA Test

Basic Information

• Brand Name: hc2 HPV DNA Test
• Primary DI: 04053228002024
• Version / Model: 1
• Catalog Number: 5198-1220
• Company Name: QIAGEN SCIENCES INC.
• Labeler DUNS: 008675485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4d4c78d4-77eb-44c9-bda8-3d030eae6469

Device Description

digene® HC2 HPV DNA Test (Low-Risk HPV and High-Risk HPV)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
49991	Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple strains of human papillomavirus (HPV) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228002024	GS1

Premarket Submissions

Submission Number	Supplement Number
P890064	000