DIFFTROL 5300100142

GUDID 00856605006080

Whole Blood Hematology Control

HORIBA INSTRUMENTS INCORPORATED

Full blood count IVD, control

• Primary Device ID: 00856605006080
• NIH Device Record Key: 116d3ff3-1c3c-4010-8ef9-92680269483c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIFFTROL
• Version Model Number: 12x3 mL
• Catalog Number: 5300100142
• Company DUNS: 052845583
• Company Name: HORIBA INSTRUMENTS INCORPORATED
• Device Count: 1
• DM Exempt: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856605006080 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [DIFFTROL]

• 00856605006097: Whole Blood Hematology Control
• 00856605006080: Whole Blood Hematology Control
• 00856605006073: Whole Blood Hematology Control
• 00856605006066: Whole Blood Hematology Control