FDA.reportPublic FDA data

Metafer

Primary DI
04250406460007
Brand
Metafer
Company
MetaSystems Hard & Software GmbH
Model
Microscopic image acquisition
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IBKMicroscope, Fluorescence/U.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBKMicroscope, Fluorescence/U.V.Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250406460007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250406460007042504064600074250406460007

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
329631642
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250406401000NeonMedical Device Data System2023-07-10
04250406400003IkarosKaryotyping System2016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340246dIFine M1 with cameraVISIA LAB SRLIBK2025-07-31
08800112400192cCeLLVPIX Medical, Inc.IBK2023-12-05
08800112400208cCeLLVPIX Medical, Inc.IBK2023-12-05
08800112400215cCeLLVPIX Medical, Inc.IBK2023-12-05
04049016159018UNIQO 160EUROIMMUN Medizinische Labordiagnostika AGIBK2023-09-20
00664816001943LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816001950LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816001967LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002261LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002278LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002285LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002292LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002476LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816005774LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
08602920003035VivaScope 2500Caliber Imaging & Diagnostics, Inc.IBK2023-02-16
04049016147787EUROPattern Microscope LiveEUROIMMUN Medizinische Labordiagnostika AGIBK2022-12-08
05700574035099LFX-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574035105LLX-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037062LFXBIOAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037291LFXW-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037307LLXW-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01