| Primary Device ID | 30810107290041 |
| NIH Device Record Key | ea26ffcf-37f6-4a75-a167-d82e64717edd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flowflex Plus COVID-19 and 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 | |
| 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. |
| 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 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] Contains: 00810107290033 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] Contains: 00810107290033 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] Contains: 00810107290033 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] Contains: 00810107290033 Package: Carton [36 Units] In Commercial Distribution |
| GS1 | 70810107290032 [Package] Contains: 00810107290033 Package: Tray [10 Units] In Commercial Distribution |
| GS1 | 80810107290039 [Package] Contains: 70810107290032 Package: Carton [8 Units] In Commercial Distribution |
| QMN | COVID-19 Multi-Analyte Antigen Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-22 |
| Device Publish Date | 2024-08-14 |
| 30810107290041 - Flowflex Plus COVID-19 and Flu A/B Home Test | 2024-08-221 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) |
| 30810107290041 - Flowflex Plus COVID-19 and Flu A/B Home Test | 2024-08-22 1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cas |
| 10682607630308 - HealthyMe Early Detection Pregnancy Test | 2024-04-04 Early Detection Pregnancy Test |
| 10682607630544 - HealthyMe Early Detection Pregnancy Test | 2024-04-04 Early Detection Pregnancy Test |
| 20682607630558 - HealthyMe Early Detection Pregnancy Test | 2024-04-04 Early Detection Pregnancy Test |
| 20682607651256 - HealthyMe UTI Urinary Tract Infection Test Strips | 2024-04-04 Urinary Tract Infection home test with handle |
| 20682607200508 - MISSION U500 URINE ANALYZER | 2024-03-18 URINE ANALYZER |
| 20682607200515 - MISSION U500 URINE ANALYZER | 2024-03-18 URINE ANALYZER with Barcode Reader |
| 20682607660272 - Flowflex COVID-19 Antigen Home Test | 2021-11-30 Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2) |