Immco Diagnostics, Inc. 2150

GUDID 00845714003219

HeP-2 Cells Slide

IMMCO DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, reagent

• Primary Device ID: 00845714003219
• NIH Device Record Key: 5e19aaba-48b0-4e6f-ab67-dce7629288e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc.
• Version Model Number: 2150
• Catalog Number: 2150
• 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: false
• Device Combination Product: false
• Single Use: true
• 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	00845714003219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883883

FDA Product Code

• LKJ: Antinuclear Antibody, Antigen, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-02

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• 00845714004834: Lyme B. burgdorferi (IgM) Marstripe Test
• 00845714004810: Lyme B. burgdorferi (IgM) Marstripe Test
• 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