FDA.reportPublic FDA data

dIFine ANA HEp-2 Classifier

Primary DI
08059304340215
Brand
dIFine ANA HEp-2 Classifier
Company
VISIA LAB SRL
Model
dIFine ANA HEp-2 Classifier
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201956000Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.2022-04-29DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059304340215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059304340215080593043402158059304340215

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
441255829
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059304340246dIFine M1 with cameradIFine M1 with cameraFA01C2025-07-31
08059304340147dIFine P15dIFine P152025-06-27
08059304340239dIFine ANCA ClassifierdIFine ANCA Classifier2025-06-27
08059304340222dIFine DNA ClassifierdIFine DNA Classifier2024-11-08
08059304340109dIFine Automated Microscope dIFine Automated Microscope 2022-09-07
08059304340123dIFine P30dIFine P30 2023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340239dIFine ANCA ClassifierVISIA LAB SRLPIV2025-06-27
04250289504942AESKUSLIDES® ANA HEp-2-GammaAesku.Diagnostics GmbH & Co. KGDHN2025-05-27
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
08059304340222dIFine DNA ClassifierVISIA LAB SRLPIV2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2024-09-11
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2023-07-05
04250289512541HELIOS® AUTOMATED IFA SYSTEMAesku.Diagnostics GmbH & Co. KGPIV2023-06-25
00845533001861ZEUS NTx SerumZEUS SCIENTIFIC, INC.PIV2023-04-18
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGPIV2022-12-08
08059304340109dIFine Automated Microscope VISIA LAB SRLDHN2022-09-07
08059304340109dIFine Automated Microscope VISIA LAB SRLPIV2022-09-07
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.PIV2021-03-31
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026578MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
04049016107057IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2020-08-28
04260186125096HELIOSAesku.Systems GmbH & Co. KGDHN2020-03-02
04260186125096HELIOSAesku.Systems GmbH & Co. KGPIV2020-03-02
M74900IN2201Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08