PathVysion 02J01-035

GUDID 00884999001756

PathVysion HER-2 DNA Probe Kit

ABBOTT MOLECULAR INC.

C-erbB2/Her2/neu oncoprotein IVD, reagent
Primary Device ID00884999001756
NIH Device Record Key84c4fdb0-449a-428e-8eff-67fcc035424f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathVysion
Version Model Number02J01-035
Catalog Number02J01-035
Company DUNS878263359
Company NameABBOTT MOLECULAR 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 Usetrue
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

Customer Support Contacts

Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999001756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVDSYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2014-11-20

On-Brand Devices [PathVysion]

00884999001855ProbeChek PathVysion HER-2/neu Normal Control Slides
00884999001831ProbeChek PathVysion HER-2/neu Cut-Off Control Slides
00884999001763PathVysion HER-2 DNA Probe Kit
00884999001756PathVysion HER-2 DNA Probe Kit
00884999001732PathVysion HER-2 DNA Probe Kit

Trademark Results [PathVysion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PATHVYSION
PATHVYSION
75584424 not registered Dead/Abandoned
Vysis, Inc.
1998-11-06
PATHVYSION
PATHVYSION
75549557 2496630 Live/Registered
ABBOTT MOLECULAR INC.
1998-09-08

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