Immco Diagnostics, Inc 1108

GUDID 00845714002045

ImmuGlo HEp-2 ELITE IFA

IMMCO DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device ID00845714002045
NIH Device Record Keye608f60c-190d-4caa-85b0-0664e3af3ad7
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmco Diagnostics, Inc
Version Model Number1108
Catalog Number1108
Company DUNS079935300
Company NameIMMCO DIAGNOSTICS, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-537-8378
Emailinfo@immco.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845714002045 [Primary]

FDA Product Code

DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-03
Device Publish Date2018-07-03

On-Brand Devices [Immco Diagnostics, Inc]

00845714004827Enhanced Anti-RNA POL lll Antibody ELISA
00845714002427B2GP1 IgA ELISA
00845714002045ImmuGlo HEp-2 ELITE IFA

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