Beckman Coulter PK TP System PH3000

GUDID 04987270226964

FUJIREBIO INC.

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

• Primary Device ID: 04987270226964
• NIH Device Record Key: 58abf7ef-08a5-4ba5-a233-2cff6eafe09a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter PK TP System
• Version Model Number: 226964
• Catalog Number: PH3000
• Company DUNS: 710873907
• Company Name: FUJIREBIO 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: 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

Customer Support Contacts

• Phone: 800-223-0125
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270226964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060062

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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