TPHA Screen Positive Control and TPHA Screen Negat 0066828

GUDID 10888234001508

TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product

IMMUCOR, INC.

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

• Primary Device ID: 10888234001508
• NIH Device Record Key: f3adb902-ef46-47cc-8f7b-a0ad35a0a1a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPHA Screen Positive Control and TPHA Screen Negat
• Version Model Number: 0066828
• Catalog Number: 0066828
• Company DUNS: 061446282
• Company Name: IMMUCOR, 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: false
• 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: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001508 [Primary]

FDA Product Code

• MYR: Test,Donor,Syphilis,Antigens,Treponemal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-15

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