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 TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.

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 TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.
TPHA Screen Diluent - 0066827

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MYR

Device Name: Test, Donor, Syphilis, Antigens, Treponemal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3830

Third Party Flag: N

Medical Specialty: MI

Device Id: 10888234001492

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A