Cervista PRD-00804

GUDID 15420045500150

Hologic, Inc.

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID15420045500150
NIH Device Record Key8dbe6cea-bc78-49a6-92cc-b91f0a1b66a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervista
Version Model NumberHPV HR (768 Reactions)
Catalog NumberPRD-00804
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045500150 [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 Date2014-07-30

On-Brand Devices [Cervista]

15420045509627Invader Ancillaries
15420045500167HPV 16 18
15420045500150HPV HR (768 Reactions)
15420045500143HPV HR (96 Reactions)

Trademark Results [Cervista]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CERVISTA
CERVISTA
77527790 4053374 Dead/Cancelled
HOLOGIC, INC.
2008-07-21
CERVISTA
CERVISTA
77396554 3709488 Live/Registered
Third Wave Technologies, Inc.
2008-02-13

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