R&D CBC-XR Hematology Control

GUDID 00815762020537

CBC-XR 12 x 4.5 mL (4 each Levels 1, 2 and 3)

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Full blood count IVD, control

• Primary Device ID: 00815762020537
• NIH Device Record Key: db9f37db-a0b8-42f7-bf6b-e62c541898bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R&D CBC-XR Hematology Control
• Version Model Number: XR004
• Company DUNS: 087248183
• Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815762020537 [Primary]

FDA Product Code

• JPK: Mixture, Hematology Quality Control

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: 2024-04-10
• Device Publish Date: 2024-04-02

On-Brand Devices [R&D CBC-XR Hematology Control]

• 00815762020605: CBC-XR 6 x 4.5 mL (2 each Levels 1, 2 and 3)
• 00815762020537: CBC-XR 12 x 4.5 mL (4 each Levels 1, 2 and 3)
• 00815762020520: CBC-XR 10 x 4.5 mL (5 each Levels 2 and 3)