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 Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control Triglyceride IVD, control 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

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

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

Devices Manufactured by OSANG HEALTHCARE Co., Ltd.

• 08809115903297 - OHC COVID-19/ Flu Antigen Test Pro: 2024-05-20 25 Test / Kit
• 08809115904423 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2024-05-20 2 Test / Kit
• 08809115904119 - CURO L5 Glucose test strip: 2022-10-04 Glucose test strip(25T)
• 08809115904225 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 25 Test Kit / Box
• 08809115904232 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 5 Test Kit / Box
• 08809115904249 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 4 Test Kit / Box
• 08809115904256 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 2 Test Kit / Box
• 08809115904263 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 1 Test Kit / Box