Newfoundland Cholesterol Test

GUDID 08806141303701

DFI CO.,LTD

Total cholesterol lipid IVD, reagent

• Primary Device ID: 08806141303701
• NIH Device Record Key: 1e89cc2b-2569-4c6f-a6f2-d224a19a3bc0
• Commercial Distribution Discontinuation: 2024-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Newfoundland Cholesterol Test
• Version Model Number: 6450
• Company DUNS: 688779180
• Company Name: DFI CO.,LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
• 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	08806141303701 [Primary]

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

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: 2024-06-06
• Device Publish Date: 2024-05-29

Devices Manufactured by DFI CO.,LTD

• 08806141303701 - Newfoundland Cholesterol Test: 2024-06-06
• 08806141303701 - Newfoundland Cholesterol Test: 2024-06-06
• 08806141303497 - One+Step 10A: 2023-10-24 One device is included 100 test strips
• 08806141303480 - One+Step UTI: 2023-10-23 The one device included 100 Strips
• 08806141301592 - QTEST K: 2022-10-24 100 strips/ 1 bottle
• 08806141302025 - One+Step Protein: 2022-10-11 100strip/1 bottle
• 08806141302643 - One+Step pH: 2022-10-11 100strips/ 1 bottle
• 08806141302650 - One+Step Ketone: 2022-10-11 100strip / 1 bottle
• 08806141303060 - One+Step Salive & Urine pH: 2022-10-11 100strips/ 1 bottle