FDA.reportPublic FDA data

Image Navigator®

Primary DI
M749IN1101
Brand
Image Navigator®
Company
IMMUNO CONCEPTS INC
Model
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
OTC
false
Sterile
false
Single use
false

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
M749IN1101PrimaryHIBCC0

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
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
false
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
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
M74900IN1101Image 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