PK7400

GUDID 14987666543344

PK7400 Automated Microplate System

Beckman Coulter, Inc.

Blood group/antibody screening analyser IVD, automated

• Primary Device ID: 14987666543344
• NIH Device Record Key: 4b8beca2-2253-4cc6-8dda-aa7412396bff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PK7400
• Version Model Number: B53299
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14987666543344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180292

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-14
• Device Publish Date: 2020-07-06

Devices Manufactured by Beckman Coulter, Inc.

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