Immco Diagnostics Inc. 2284

GUDID 00845714004100

DFS-70 Positive Control

IMMCO DIAGNOSTICS, INC.

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

• Primary Device ID: 00845714004100
• NIH Device Record Key: 16d62cf4-ad56-4950-aec9-d59c9cff5563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics Inc.
• Version Model Number: 2284
• Catalog Number: 2284
• 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	00845714004100 [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

Devices Manufactured by IMMCO DIAGNOSTICS, INC.

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• 00845714000942 - IMMCO DIAGNOSTICS: 2019-01-08 Anti-Skin (IC) Antibody IFA Kit
• 00845714000959 - IMMCO DIAGNOSTICS: 2019-01-08 Anti-Skin (IC) Antibody IFA Kit
• 00845714000966 - IMMCO DIAGNOSTICS: 2019-01-08 Anti-Skin (IC) Antibody IFA Kit
• 00845714003257 - IMMCO DIAGNOSTICS: 2019-01-08 Intercellular Positive
• 00845714003707 - IMMCO DIAGNOSTICS: 2019-01-08 Pemphigus Foliaceus Control
• 00845714003714 - IMMCO DIAGNOSTICS: 2019-01-08 Pemphigold Positive