FDA.reportPublic FDA data

Image Navigator®

Primary DI
M74900IN1101
Brand
Image Navigator®
Company
IMMUNO CONCEPTS INC
Model
IN110
Catalog number
IN110
Device description
Automated microscope system for immunofluorescent determination of autoantibodies.
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K160265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160265000Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.2016-06-17DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M74900IN1101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automatedA mains electricity (AC-powered) 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. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
038271904
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7491216001R1Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12160-01R12160-01R2026-02-05
M7491208002T1Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-02 (T)12080-02 (T)2025-06-03
M7491208003T1Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-03 (T)12080-03 (T)2025-06-03
M7492075B11HEp-2000® IgG Fluorescent ANA-Ro Test System2075B (1)2075B (1)2025-06-03
M7492280CSROT1HEp-2000® IgG Fluorescent ANA-Ro Test System2280CS-Ro (T)2280CS-Ro (T)2025-06-03
M7492280CST1Fluorescent ANA Test System2280CS (T)2280CS (T)2025-06-03
M7498216ROT1HEp-2000® IgG Fluorescent ANA-Ro Test System8216-Ro (T)8216-Ro (T)2025-06-03
M7498262ROT1HEp-2000® Fluorescent ANA-Ro Test System8262-Ro (T)8262-Ro (T)2025-06-03
M7498264ROT1HEp-2000® IgG Fluorescent ANA-Ro Test System8264-Ro (T)8264-Ro (T)2025-06-03
M7498400RO1HEp-2000® Fluorescent ANA-Ro Test System8400-Ro8400-Ro2016-09-24
M7490083231Fluorescent ANA Test System832383232023-10-06
M7498318RO1HEp-2000® IgG Fluorescent ANA-Ro Test System8318-Ro8318-Ro2017-06-07
M7498262RO1HEp-2000® Fluorescent ANA-Ro Test System8262-Ro8262-Ro2016-09-24
M7492040CS1Fluorescent ANA Test System2040CS2040CS2024-02-27
M7492075B1HEp-2000® IgG Fluorescent ANA-Ro Test System2075B (1)2075B (1)2024-02-27
M7490831121Fluorescent ANA Test System8311.28311.22022-12-06
M7498303RO1HEp-2000® IgG Fluorescent ANA-Ro Test System8303-Ro8303-Ro2022-08-09
M74902140B1HEp-2 Fluorescent w/cs ANA Test System2140B2140B2021-04-28
M74902280B1HEp-2 Fluorescent w/cs ANA Test System2280B2280B2021-04-28
M7492280BRO1HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System2280B-Ro2280B-Ro2021-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340239dIFine ANCA ClassifierVISIA LAB SRLPIV2025-06-27
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
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
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 SRLPIV2022-09-07
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.PIV2021-03-31
04049016107057IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2020-08-28
04260186125096HELIOSAesku.Systems GmbH & Co. KGPIV2020-03-02
M74900IN2201Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
M749IN1101Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
M749IN2201Image Navigator®IMMUNO CONCEPTS INCPIV2019-04-08
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108559IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108566IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108634IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108641IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108658IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108665IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108733EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108740EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108757EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04
04049016108764EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2018-06-04