AimStrip Tandem Total Triglycerides Control Solution

GUDID 00695684774127

Lipid measuring meter and Triglycerides test strip control solution level 1,2

OSANG HEALTHCARE Co., Ltd.

Triglyceride IVD, control

• Primary Device ID: 00695684774127
• NIH Device Record Key: 4343349a-bc7e-476b-a2de-0f24b85f4d0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AimStrip Tandem Total Triglycerides Control Solution
• Version Model Number: ILM-0001A
• Company DUNS: 688195374
• Company Name: OSANG HEALTHCARE Co., Ltd.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684774127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-03-23
• Device Publish Date: 2020-03-13

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