Beckman Coulter PK CMV-PA System PA2300

GUDID 04987270227541

FUJIREBIO INC.

Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent Cytomegalovirus (CMV) total antibody IVD, reagent

• Primary Device ID: 04987270227541
• NIH Device Record Key: c00b6241-ab88-4398-9827-4b8b41549338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter PK CMV-PA System
• Version Model Number: 227541
• Catalog Number: PA2300
• 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: 800-447-5852
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling 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 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling 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 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling 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 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling 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 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling 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 8 Degrees Celsius
• 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	04987270227541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070030

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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