R&D CBC-DH Hematology Control DH004

GUDID 00815762026348

12 x 3 mL; 4 each level low, normal, high

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Full blood count IVD, control

• Primary Device ID: 00815762026348
• NIH Device Record Key: 16f58c0a-97f1-465c-8e61-b51272243d22
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: R&D CBC-DH Hematology Control
• Version Model Number: DH004
• Catalog Number: DH004
• Company DUNS: 087248183
• Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00815762026348 [Primary]

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: 2023-07-10
• Device Publish Date: 2023-06-30

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

• 00815762026348: 12 x 3 mL; 4 each level low, normal, high
• 00815762026331: 6 x 3 mL; 2 each level low, normal & high