dIFine DNA Classifier

GUDID 08059304340222

VISIA LAB SRL

Laboratory instrument/analyser application software IVD
Primary Device ID08059304340222
NIH Device Record Key2108a669-533d-4f94-8ea7-6ef322777693
Commercial Distribution StatusIn Commercial Distribution
Brand NamedIFine DNA Classifier
Version Model NumberdIFine DNA Classifier
Company DUNS441255829
Company NameVISIA LAB SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059304340222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTLAnti-Dna Indirect Immunofluorescent Solid Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-18
Device Publish Date2024-11-08

Devices Manufactured by VISIA LAB SRL

08059304340215 - dIFine ANA HEp-2 Classifier2024-11-18
08059304340222 - dIFine DNA Classifier2024-11-18
08059304340222 - dIFine DNA Classifier2024-11-18
08059304340123 - SP302023-06-13
08059304340109 - Zeus dIFine2022-09-15

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