FDA.reportPublic FDA data

dIFine M1 with camera

Primary DI
08059304340246
Brand
dIFine M1 with camera
Company
VISIA LAB SRL
Model
dIFine M1 with camera
Catalog number
FA01C
Published
2025-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08059304340246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059304340246080593043402468059304340246

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescence light microscopeA magnification instrument in which light (typically ultraviolet) that has been absorbed by the specimen and re-emitted at a longer wavelength is observed (as visible light) so that the specimen is visible through the eyepiece. This device is typically used in the laboratory for histopathology and microbiology, commonly in conjunction with fluorescent dyes. Appropriate filters are used to select the correct wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incident wavelength from the fluorescent light source (i.e., the specimen).

Regulatory Flags#

DUNS number
441255829
Device count
1
DM exempt
false
Premarket exempt
true
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
08059304340147dIFine P15dIFine P152025-06-27
08059304340239dIFine ANCA ClassifierdIFine ANCA Classifier2025-06-27
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
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
04250406460007MetaferMetaSystems Hard & Software GmbHIBK2023-06-09
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