Aptiva® System Cleaning Solution Kit

GUDID 00195126000871

The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module (OM) and flush the system.

INOVA DIAGNOSTICS, INC.

Instrument/analyser cleaning agent IVD
Primary Device ID00195126000871
NIH Device Record Key2461cb2f-de70-4ce3-bfe0-38fe918764a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAptiva® System Cleaning Solution Kit
Version Model NumberAC1003
Company DUNS188354831
Company NameINOVA DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100195126000871 [Primary]
GS108430793041140 [Previous]

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-26
Device Publish Date2024-03-18

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Trademark Results [Aptiva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APTIVA
APTIVA
88071814 not registered Live/Pending
Inova Diagnostics, Inc.
2018-08-09
APTIVA
APTIVA
87554737 not registered Dead/Abandoned
BELSONO MANAGEMENT GROUP, LLC
2017-08-03
APTIVA
APTIVA
76714382 4472883 Live/Registered
APTIVA COMMUNICATION DEVICES, LLC
2013-06-14
APTIVA
APTIVA
76612969 3272730 Dead/Expired
APTIVA COMMUNICATION DEVICES, LLC
2004-09-27
APTIVA
APTIVA
76035198 not registered Dead/Abandoned
AVENTIS CROPSCIENCE S.A. (Societe Anonyme)
2000-04-26
APTIVA
APTIVA
74520580 1995953 Dead/Cancelled
LENOVO (SINGAPORE) PTE. LTD.
1994-05-06

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