IMMCO DIAGNOSTIC 2510

GUDID 00845714004186

Counterstain

IMMCO DIAGNOSTICS, INC.

Evans blue solution IVD

• Primary Device ID: 00845714004186
• NIH Device Record Key: 8e95b507-a776-49fd-86a3-684f24eac19f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMCO DIAGNOSTIC
• Version Model Number: 2510
• Catalog Number: 2510
• 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: 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	00845714004186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060157

FDA Product Code

• DBL: Multiple Autoantibodies, Indirect Immunofluorescent, 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: 2016-10-27

On-Brand Devices [IMMCO DIAGNOSTIC]

• 00845714004186: Counterstain
• 00845714002199: IgA FITC Conjugate w/ Evans Blue