Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T C131-2041

GUDID 10682607690098

Cholesterol lipid panel test device - 5T

Acon Laboratories, Inc.

Total cholesterol lipid IVD, kit, spectrophotometry

• Primary Device ID: 10682607690098
• NIH Device Record Key: 676d0d2a-71c8-4ec8-9bdc-f97ccf28abb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T
• Version Model Number: C131-2041
• Catalog Number: C131-2041
• Company DUNS: 781100966
• Company Name: Acon Laboratories, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• 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: true

Customer Support Contacts

• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607003624 [Unit of Use]
GS1	00682607690091 [Primary]
GS1	10682607690098 [Package]; Contains: 00682607690091; Package: Inner Pack [12 Units]; In Commercial Distribution
GS1	20682607690095 [Package]; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163406

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: 2026-03-17
• Device Publish Date: 2026-03-09

Devices Manufactured by Acon Laboratories, Inc.

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• 10682607690098 - Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T: 2026-03-17Cholesterol lipid panel test device - 5T
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