Beckman Coulter PK TP System Control Set

GUDID 00850212007041

FUJIREBIO US, INC.

Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control

• Primary Device ID: 00850212007041
• NIH Device Record Key: 653781ec-764b-468e-8068-f780fcf4af6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter PK TP System Control Set
• Version Model Number: PH3502
• Company DUNS: 029385775
• Company Name: FUJIREBIO US, 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: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx
• Phone: 800-447-5852
• Email: xx@xx.xx

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060062

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents
• 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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