TPHA Screen Diluent 0066827

GUDID 10888234001492

TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPH

IMMUCOR, INC.

Treponema pallidum total antibody IVD, kit, agglutination

• Primary Device ID: 10888234001492
• NIH Device Record Key: 236b1c21-0bfc-4654-9659-b26050bd765a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPHA Screen Diluent
• Version Model Number: 0066827
• Catalog Number: 0066827
• 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	10888234001492 [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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