dIFine ANA HEp-2 Classifier

GUDID 08059304340215

Laboratory instrument/analyser application software IVD

Primary Device ID	08059304340215
NIH Device Record Key	56cef560-0e9c-4232-be16-323a7cb272f4
Commercial Distribution Status	In Commercial Distribution
Brand Name	dIFine ANA HEp-2 Classifier
Version Model Number	dIFine ANA HEp-2 Classifier
Company DUNS	441255829
Company Name	VISIA LAB SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08059304340215 [Primary]

DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Steralize Prior To Use	false
Device Is Sterile	false