FDA.reportPublic FDA data

dIFine ANCA Classifier

Primary DI
08059304340239
Brand
dIFine ANCA Classifier
Company
VISIA LAB SRL
Model
dIFine ANCA Classifier
Published
2025-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243776000Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus Scientific2025-05-07MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059304340239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059304340239080593043402398059304340239

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).

Regulatory Flags#

DUNS number
441255829
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08059304340215dIFine ANA HEp-2 ClassifierdIFine ANA HEp-2 Classifier2024-11-08
08059304340222dIFine DNA ClassifierdIFine DNA Classifier2024-11-08
08059304340123dIFine P30dIFine P302023-06-05
08059304340109dIFine Automated MicroscopedIFine Automated Microscope2022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533001984Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001991Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
08426950627692QUANTA Flash PR3 ReagentsINOVA DIAGNOSTICS, INC.MOB2024-12-13
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLPIV2024-11-08
08059304340222dIFine DNA ClassifierVISIA LAB SRLPIV2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2024-09-11
08426950627685QUANTA Flash® MPO ReagentsINOVA DIAGNOSTICS, INC.MOB2023-12-14
04049016159704EUROPLUS Granulocyte Mosaic 32EUROIMMUN Medizinische Labordiagnostika AGMOB2023-10-05
04048474027761Myeloperoxidase IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027778ANCA Screen IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027785Proteinase-3 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
00840239035967c-ANCA (PR3) ELISADRG International IncMOB2023-08-25
00840239035974pANCA (MPO) ELISADRG International IncMOB2023-08-25
00840239027764Myeloperoxidase IgG ELISADRG International IncMOB2023-08-23
00840239027771ANCA Screen IgG ELISADRG International IncMOB2023-08-23
00840239027788Proteinase-3 IgG ELISADRG International IncMOB2023-08-23
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2023-07-05
04250289512541HELIOS® AUTOMATED IFA SYSTEMAesku.Diagnostics GmbH & Co. KGPIV2023-06-25
00813545029036MBO IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
00813545029043PR3 IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
00845533001861ZEUS NTx SerumZEUS SCIENTIFIC, INC.PIV2023-04-18
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGPIV2022-12-08
B3507204300Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
B3507204400Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
08059304340109dIFine Automated MicroscopeVISIA LAB SRLPIV2022-09-07