QUCARE®Self Total Cholesterol

GUDID 08806141302896

The device is included 2 pouch

DFI CO.,LTD

Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent

• Primary Device ID: 08806141302896
• NIH Device Record Key: ff31ed3d-62cc-4a79-8e6b-c9a34229be2f
• Commercial Distribution Discontinuation: 2022-07-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QUCARE®Self Total Cholesterol
• Version Model Number: 6407
• Company DUNS: 688779180
• Company Name: DFI CO.,LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806141302896 [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: 2022-08-03
• Device Publish Date: 2022-07-26

On-Brand Devices [QUCARE®Self Total Cholesterol ]

• 08806141302674: 6400P
• 08806141302896: The device is included 2 pouch