digene® Wash Buffer Concentrate 5100-00047

GUDID 14053228002014

digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate)

QIAGEN SCIENCES INC.

Human papillomavirus (HPV) antigen IVD, reagent Human papillomavirus (HPV) antigen IVD, reagent
Primary Device ID14053228002014
NIH Device Record Key716f2a51-0d44-4a16-9cdb-0b53b7561f8c
Commercial Distribution StatusIn Commercial Distribution
Brand Namedigene® Wash Buffer Concentrate
Version Model Number1
Catalog Number5100-00047
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 Kitfalse
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
GS114053228002014 [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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Trademark Results [digene]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIGENE
DIGENE
74551283 1958407 Live/Registered
QIAGEN GAITHERSBURG, LLC
1994-07-20
DIGENE
DIGENE
73567948 1412689 Dead/Cancelled
DIGENE, LTD.
1985-11-12
DIGENE
DIGENE
72067582 0700401 Dead/Cancelled
American Home Products Corporation
1959-02-12

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