Mission Cholesterol Control Solution C121-2011

GUDID 10682607690081

Cholesterol control solution

Acon Laboratories, Inc.

Total cholesterol lipid IVD, kit, spectrophotometry

• Primary Device ID: 10682607690081
• NIH Device Record Key: 89ffbae5-6368-4c33-bd74-728051e1a2a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mission Cholesterol Control Solution
• Version Model Number: C121-2011
• Catalog Number: C121-2011
• Company DUNS: 781100966
• Company Name: Acon Laboratories, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	00682607690084 [Primary]
GS1	10682607690081 [Package]; Contains: 00682607690084; Package: Inner Pack [12 Units]; In Commercial Distribution
GS1	20682607690088 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163406

FDA Product Code

• LBR: LDL & VLDL PRECIPITATION, HDL

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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• 00682607690060 - Mission Cholesterol Meter: 2026-03-17 Cholesterol meter
• 10682607690074 - Mission Cholesterol Optical Check Device: 2026-03-17 Meter optics checker
• 10682607690081 - Mission Cholesterol Control Solution: 2026-03-17Cholesterol control solution
• 10682607690081 - Mission Cholesterol Control Solution: 2026-03-17 Cholesterol control solution
• 10682607690098 - Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T: 2026-03-17 Cholesterol lipid panel test device - 5T
• 10682607541055 - On Call Lancets 30G: 2026-02-27 Lancets
• 20682607200485 - Mission U120 Smart Urine Analyzer: 2026-02-16 URINE ANALYZER
• 20682607200492 - Mission U120 Smart Urine Analyzer: 2026-02-16 URINE ANALYZER with Barcode Reader