Beckman Coulter® PK® Systems Control 17317

GUDID 23661562173178

Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System

DIAGAST

Antisera matrix (non-reactive) IVD, control

• Primary Device ID: 23661562173178
• NIH Device Record Key: ecbada22-286e-4b0b-b918-4202d8af06ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter® PK® Systems Control
• Version Model Number: 17317
• Catalog Number: 17317
• Company DUNS: 381527001
• Company Name: DIAGAST
• Device Count: 10
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx
• Phone: 800-447-5852
• Email: xxx@xx.xx

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	13661562173171 [Unit of Use]
GS1	23661562173178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060024

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

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: 2016-01-12

Devices Manufactured by DIAGAST

• 23661562495584 - Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63): 2020-10-28 Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
• 23661562105261 - Anti-D (RH1) IgM+IgG: 2020-03-11 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to
• 23661562105445 - LISS: 2018-09-12 Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohemato
• 23661562105438 - Neg Control: 2018-07-06 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
• 23661562173178 - Beckman Coulter® PK® Systems Control: 2018-07-06Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562173178 - Beckman Coulter® PK® Systems Control: 2018-07-06 Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562173307 - Beckman Coulter® PK® Systems Bromelin: 2018-07-06 Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System
• 23661562105209 - Anti-A (AB01): 2018-06-01 Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system
• 23661562105216 - Anti-B (AB02): 2018-06-01 Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system b