Mission Urinary Tract Infection (UTI) Test strips

GUDID 20682607610031

ACON LABORATORIES, INC.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 20682607610031
• NIH Device Record Key: 42f4ae5e-6101-41ea-8890-33b2e0f63985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mission Urinary Tract Infection (UTI) Test strips
• Version Model Number: U031-021 2N
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, INC.
• Device Count: 3
• 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: true
• 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: 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
• 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
• 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
• 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
• 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	00682607003433 [Primary]
GS1	00682607610037 [Unit of Use]
GS1	10682607610034 [Package]; Contains: 00682607003433; Package: Inner Pack [6 Units]; In Commercial Distribution
GS1	20682607610031 [Package]; Contains: 10682607610034; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• LJX: TEST, URINE LEUKOCYTE

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: 2025-05-20
• Device Publish Date: 2025-05-12

Devices Manufactured by ACON LABORATORIES, INC.

• 20682607610031 - Mission Urinary Tract Infection (UTI) Test strips: 2025-05-20
• 20682607610031 - Mission Urinary Tract Infection (UTI) Test strips: 2025-05-20
• 20682607200676 - Mission Liquid Urine Controls: 2025-04-25 Liquid Urine Control
• 20682607200683 - Mission Liquid Urine Controls: 2025-04-25 Liquid Urine Control
• 20682607200690 - Mission Liquid Urine Controls: 2025-04-25 Liquid Urine Control
• 20682607200706 - Mission Liquid Urine Controls: 2025-04-25 Liquid Urine Control
• 00682607630653 - HealthyMe Early Detection Pregnancy Test: 2025-02-10 Early Detection Pregnancy Test
• 10682607630582 - HealthyMe Digital Pregnancy Test: 2025-02-05 Early Detection Digital Pregnancy Test
• 10682607630599 - HealthyMe Digital Pregnancy Test: 2025-02-05 Early Detection Digital Pregnancy Test