PK7400 TP HA REAGENT

GUDID 05060515140030

PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.

NEWMARKET BIOMEDICAL LIMITED

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

• Primary Device ID: 05060515140030
• NIH Device Record Key: ed69718e-11ba-4105-8057-62114e29da4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PK7400 TP HA REAGENT
• Version Model Number: B11186
• Company DUNS: 217095816
• Company Name: NEWMARKET BIOMEDICAL LIMITED
• 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: true
• 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

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	05060515140030 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

Devices Manufactured by NEWMARKET BIOMEDICAL LIMITED

• 05060515140030 - PK7400 TP HA REAGENT: 2019-11-22PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
• 05060515140030 - PK7400 TP HA REAGENT: 2019-11-22 PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detec
• 05060515140047 - PK7400 TP HA CONTROLS: 2019-11-22 PK7400 TP HA CONTROLS is intended for use with the PK7400 TP HA REAGENT (B11186) for the qualitative screening of blood and plas