ANAFLUOR™ Combo-Pak

GUDID 08056771600927

Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay

Primary Device ID	08056771600927
NIH Device Record Key	14c6a1d4-a124-41a7-8261-e25b6d078b6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ANAFLUOR™ Combo-Pak
Version Model Number	1812
Company DUNS	033429783
Company Name	Diasorin Inc.
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08056771600927 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

08056771600811 - ANAFLUOR™	2026-02-09
08056771600828 - ANAFLUOR™	2026-02-09
08056771600835 - ANAFLUOR ™	2026-02-09
08056771600842 - ANAFLUOR™	2026-02-09
08056771600859 - ANAFAST™ ANA Fluorescent Test System 240 Wells	2026-02-09
08056771600897 - CT-3 Immunoscreen Fluoro-Kit™	2026-02-09
08056771600903 - CT-2 Immunoscreen Fluoro-Kit™	2026-02-09
08056771600910 - RS Fluoro-Kit™	2026-02-09

Mark Image Registration \| Serial	Company Trademark Application Date
ANAFLUOR 76421528 2766451 Live/Registered	DiaSorin Inc. 2002-06-14
ANAFLUOR 73405023 1282888 Dead/Cancelled	Clinical Sciences Inc. 1982-12-06