FDA.reportPublic FDA data

NOVA View® Automated Fluorescence Microscope

Primary DI
08426950621614
Brand
NOVA View® Automated Fluorescence Microscope
Company
INOVA DIAGNOSTICS, INC.
Model
NV2000
Device description
NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140039000
K153150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140039000NOVA View Automated Fluorescense MicroscopeInova Diagnostics, Inc.2015-04-09PIV
K153150000AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000Inova Diagnostics, Inc.2015-11-24PIV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950621614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950621614084269506216148426950621614

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automated/semi-automatedAn electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com
1-800-545-9495TechSupport.na@werfen.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31

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