dIFine M1 with camera FA01C

GUDID 08059304340246

VISIA LAB SRL

Fluorescence light microscope
Primary Device ID08059304340246
NIH Device Record Keya6f3663e-81ad-415c-8b04-39f0c21651d7
Commercial Distribution StatusIn Commercial Distribution
Brand NamedIFine M1 with camera
Version Model NumberdIFine M1 with camera
Catalog NumberFA01C
Company DUNS441255829
Company NameVISIA LAB SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059304340246 [Primary]

FDA Product Code

IBKMicroscope, Fluorescence/U.V.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-08
Device Publish Date2025-07-31

Devices Manufactured by VISIA LAB SRL

08059304340246 - dIFine M1 with camera2025-08-08
08059304340246 - dIFine M1 with camera2025-08-08
08059304340147 - dIFine P152025-07-07
08059304340239 - dIFine ANCA Classifier2025-07-07
08059304340215 - dIFine ANA HEp-2 Classifier2024-11-18
08059304340222 - dIFine DNA Classifier2024-11-18
08059304340123 - SP302023-06-13
08059304340109 - Zeus dIFine2022-09-15

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