hc2 HPV DNA Test 5198-1220

GUDID 04053228002024

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

QIAGEN SCIENCES INC.

Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04053228002024
NIH Device Record Key4d4c78d4-77eb-44c9-bda8-3d030eae6469
Commercial Distribution StatusIn Commercial Distribution
Brand Namehc2 HPV DNA Test
Version Model Number1
Catalog Number5198-1220
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
GS104053228002024 [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

Devices Manufactured by QIAGEN SCIENCES INC.

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