ANA HEp-2 6-well Slide Pack

GUDID 08056771600934

Diasorin Inc.

Multiple antinuclear antibody (ANA) IVD, reagent
Primary Device ID08056771600934
NIH Device Record Keyaa5459ff-0d08-4054-b4c0-bdea8fb6b325
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA HEp-2 6-well Slide Pack
Version Model Number1663
Company DUNS033429783
Company NameDiasorin Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com
Phone651-439-9710
Emailinfo@diasorin.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108056771600934 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-02-09
Device Publish Date2016-09-24

Devices Manufactured by Diasorin Inc.

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08056771600828 - ANAFLUOR™2026-02-09
08056771600835 - ANAFLUOR ™2026-02-09
08056771600842 - ANAFLUOR™2026-02-09
08056771600859 - ANAFAST™ ANA Fluorescent Test System 240 Wells2026-02-09
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

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