hc2 High-Risk HPV DNA Test 5199-1220

GUDID 04053228002031

digene® HC2 High-Risk HPV DNA Test (1-Plate Kit)

QIAGEN SCIENCES INC.

Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04053228002031
NIH Device Record Key9f9aba8d-cf31-4d77-bc55-b46515410cd6
Commercial Distribution StatusIn Commercial Distribution
Brand Namehc2 High-Risk HPV DNA Test
Version Model Number1
Catalog Number5199-1220
Company DUNS008675485
Company NameQIAGEN SCIENCES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104053228002031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAQKit, Dna Detection, Human Papillomavirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-04

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

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

Trademark Results [hc2 High-Risk HPV DNA Test]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HC2 HIGH-RISK HPV DNA TEST
HC2 HIGH-RISK HPV DNA TEST
76515724 2946532 Live/Registered
QIAGEN GAITHERSBURG, LLC
2003-05-21

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