Flowflex Plus Strep A Rapid Test Cassette L03A-R0115

GUDID 20810107290143

25 Test per kit (L03A-R0115):Test Cassettes (25), Test Tubes (25), Dropper Tips (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)

Acon Laboratories, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 20810107290143
• NIH Device Record Key: cf25e486-2e1f-4f9a-979f-4da23362198f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flowflex Plus Strep A Rapid Test Cassette
• Version Model Number: L03A-R0115
• Catalog Number: L03A-R0115
• 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: 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: true
• OTC Over-The-Counter: false

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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810107290132 [Primary]
GS1	00810107290149 [Package]; Contains: 00810107290132; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	20810107290143 [Package]; Contains: 00810107290149; Package: Carton [24 Units]; In Commercial Distribution

FDA Product Code

• GTY: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

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: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by Acon Laboratories, Inc.

• 20682607660265 - Flowflex COVID-19 Antigen Home Test: 2026-02-03 1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cas
• 20810107290143 - Flowflex Plus Strep A Rapid Test Cassette: 2025-12-0925 Test per kit (L03A-R0115):Test Cassettes (25), Test Tubes (25), Dropper Tips (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)
• 20810107290143 - Flowflex Plus Strep A Rapid Test Cassette: 2025-12-09 25 Test per kit (L03A-R0115):Test Cassettes (25), Test Tubes (25), Dropper Tips (25), Throat Swabs (25), Reagent A (1), Reagent
• 00810107290187 - Flowflex Plus Strep A Rapid Test Strip: 2025-12-09 25 Test per kit (L03A-R0125):Test Strips in pouch (25), Test Tubes (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positi
• 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