TPHA Screen 0066826

GUDID 10888234001485

TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and

IMMUCOR, INC.

Treponema pallidum total antibody IVD, kit, agglutination

• Primary Device ID: 10888234001485
• NIH Device Record Key: 64a52ad9-874c-42fe-9dd3-00c8f863ebcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPHA Screen
• Version Model Number: 0066826
• Catalog Number: 0066826
• 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	10888234001485 [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

Devices Manufactured by IMMUCOR, INC.

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