Immco Diagnostics, Inc. 1108-240

GUDID 00845714002069

ImmuGlo HEp-2 ELITE IFA

IMMCO DIAGNOSTICS, INC.

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

• Primary Device ID: 00845714002069
• NIH Device Record Key: 01933130-fe57-42a8-ba59-dbb95c818cce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc.
• Version Model Number: 1108-240
• Catalog Number: 1108-240
• Company DUNS: 079935300
• Company Name: IMMCO DIAGNOSTICS, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-537-8378
• Email: info@immco.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845714002069 [Primary]

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-03
• Device Publish Date: 2018-07-03

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• 00845714004728: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004711: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004704: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004117: HEp-2 cells / DFS-70 KO Slide
• 00845714003219: HeP-2 Cells Slide
• 00845714002670: ImmuLisa anti-gliadin IgA ELISA
• 00845714002663: ImmuLisa anti-gliadin IgG ELISA
• 00845714002526: AMA-M2 Screen ELISA
• 00845714002502: AMA-M2 IgG ELISA
• 00845714002458: B2GP1 Screen ELISA
• 00845714002441: B2GP1 IgM ELISA
• 00845714002434: B2GP1 IgG ELISA
• 00845714002069: ImmuGlo HEp-2 ELITE IFA
• 00845714002052: ImmuGlo HEp-2 ELITE IFA