hc2 High-Risk HPV DNA Test 5199-00016

GUDID 04053228002000

digene® HC2 High-Risk HPV DNA Test (4-Plate Kit)

QIAGEN SCIENCES INC.

Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04053228002000
• NIH Device Record Key: c4515308-2a34-4674-8285-a745178a6505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hc2 High-Risk HPV DNA Test
• Version Model Number: 1
• Catalog Number: 5199-00016
• Company DUNS: 008675485
• Company Name: QIAGEN SCIENCES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228002000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890064

FDA Product Code

• MAQ: Kit, Dna Detection, Human Papillomavirus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

On-Brand Devices [hc2 High-Risk HPV DNA Test]

• 04053228002031: digene® HC2 High-Risk HPV DNA Test (1-Plate Kit)
• 04053228002000: digene® HC2 High-Risk HPV DNA Test (4-Plate Kit)