Boule Con-Diff Tri-Level 501-605

GUDID 00812137010216

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Full blood count IVD, control Full blood count IVD, control

• Primary Device ID: 00812137010216
• NIH Device Record Key: fa1cac92-1905-489f-b411-2f4b56fbf940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boule Con-Diff Tri-Level
• Version Model Number: 6 x 4.5mL
• Catalog Number: 501-605
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137010216 [Primary]
GS1	00812137011794 [Unit of Use]

FDA Product Code

• JPK: Mixture, Hematology Quality Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-02

On-Brand Devices [Boule Con-Diff Tri-Level]

• 00812137011299: For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo
• 00812137010230: For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo
• 00812137010216: For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo