| Primary Device ID | 00810107290187 |
| NIH Device Record Key | 27ffc5e2-a296-4cbd-859c-29481e3a4556 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flowflex Plus Strep A Rapid Test Strip |
| Version Model Number | L03A-R0125, L03A-R0135 |
| Catalog Number | L03A-R0125, L03A-R0135 |
| 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 | true |
| 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 |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com | |
| Phone | +1(800)838-9502 |
| support@aconlabs.com |
| 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. Do not freeze. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810107290156 [Primary] |
| GS1 | 00810107290170 [Package] Contains: 00810107290156 Package: Kit Box [25 Units] In Commercial Distribution |
| GS1 | 00810107290187 [Package] Contains: 00810107290156 Package: Kit Box [25 Units] In Commercial Distribution |
| GS1 | 20810107290174 [Package] Contains: 00810107290170 Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 20810107290181 [Package] Package: Carton [24 Units] In Commercial Distribution |
| GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-09 |
| Device Publish Date | 2025-12-01 |
| 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 |
| 20682607200904 - Mission U120 Touch Urine Analyzer | 2026-02-16 URINE ANALYZER |
| 20682607200911 - Mission U120 Touch Urine Analyzer | 2026-02-16 URINE ANALYZER with Barcode Reader |
| 20682607541823 - On Call Stealth Lancing Device | 2026-02-11 1 Lancing Device |
| 00810107290033 - Flowflex Plus COVID-19 + Flu A/B Home Test | 2026-02-09 1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cas |
| 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 |