| Primary Device ID | 00810107290033 |
| NIH Device Record Key | f9181d34-90db-4d8f-b536-b5aaab275686 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flowflex Plus COVID-19 + Flu A/B Home Test |
| Version Model Number | L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 |
| Catalog Number | L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 |
| 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 | false |
| OTC Over-The-Counter | true |
| 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. 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810107290002 [Primary] |
| GS1 | 00810107290019 [Package] Contains: 00810107290002 Package: Kit Box [1 Units] In Commercial Distribution |
| GS1 | 00810107290026 [Package] Contains: 00810107290002 Package: Kit Box [2 Units] In Commercial Distribution |
| GS1 | 00810107290033 [Package] Contains: 00810107290002 Package: Kit Box [5 Units] In Commercial Distribution |
| GS1 | 00810107290040 [Package] Contains: 00810107290002 Package: Kit Box [25 Units] In Commercial Distribution |
| GS1 | 10810107290016 [Package] Contains: 00810107290019 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 10810107290023 [Package] Contains: 00810107290026 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 10810107290030 [Package] Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 20810107290013 [Package] Contains: 10810107290016 Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 20810107290020 [Package] Contains: 10810107290023 Package: Carton [18 Units] In Commercial Distribution |
| GS1 | 20810107290037 [Package] Contains: 10810107290030 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 30810107290010 [Package] Contains: 00810107290019 Package: Carton [300 Units] In Commercial Distribution |
| GS1 | 30810107290027 [Package] Contains: 00810107290026 Package: Carton [210 Units] In Commercial Distribution |
| GS1 | 30810107290034 [Package] Package: Carton [120 Units] In Commercial Distribution |
| GS1 | 30810107290041 [Package] Contains: 00810107290040 Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 40810107290017 [Package] Contains: 00810107290019 Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 40810107290024 [Package] Contains: 00810107290026 Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 40810107290031 [Package] Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 50810107290014 [Package] Contains: 40810107290017 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 50810107290021 [Package] Contains: 40810107290024 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 50810107290038 [Package] Contains: 40810107290031 Package: Carton [6 Units] In Commercial Distribution |
| GS1 | 60810107290011 [Package] Contains: 00810107290019 Package: Carton [48 Units] In Commercial Distribution |
| GS1 | 60810107290028 [Package] Contains: 00810107290026 Package: Carton [48 Units] In Commercial Distribution |
| GS1 | 60810107290035 [Package] Package: Carton [36 Units] In Commercial Distribution |
| GS1 | 70810107290032 [Package] Package: Tray [10 Units] In Commercial Distribution |
| GS1 | 80810107290015 [Package] Contains: 00810107290019 Package: Carton [252 Units] In Commercial Distribution |
| GS1 | 80810107290039 [Package] Contains: 70810107290032 Package: Carton [8 Units] In Commercial Distribution |
| SCA | Multi-analyte respiratory virus antigen detection test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-30 |
| 20682607541823 - On Call Stealth Lancing Device | 2026-02-11 1 Lancing Device |
| 00810107290033 - Flowflex Plus COVID-19 + Flu A/B Home Test | 2026-02-091 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) |
| 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 |
| 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 |