| Primary Device ID | 20682607660265 |
| NIH Device Record Key | 7d8e24d8-3779-41a2-b45d-264705801062 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flowflex COVID-19 Antigen Home Test |
| Version Model Number | L031-118B5, L031-125M5, L031-125N5, L031-125P5 |
| Catalog Number | L031-118B5, L031-125M5, L031-125N5, L031-125P5 |
| 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 |
| 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 | 00682607002306 [Primary] |
| GS1 | 00682607660261 [Package] Contains: 00682607002306 Package: Kit Box [1 Units] In Commercial Distribution |
| GS1 | 00682607660278 [Package] Contains: 00682607002306 Package: Kit Box [2 Units] In Commercial Distribution |
| GS1 | 00682607660285 [Package] Contains: 00682607002306 Package: Kit Box [5 Units] In Commercial Distribution |
| GS1 | 00682607660476 [Package] Contains: 00682607002306 Package: Kit Box [25 Units] In Commercial Distribution |
| GS1 | 10682607533302 [Package] Contains: 00682607660261 Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 10682607533319 [Package] Contains: 00682607660278 Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 10682607533326 [Package] Contains: 00682607660285 Package: Inner Pack [6 Units] In Commercial Distribution |
| GS1 | 10682607660268 [Package] Contains: 00682607660261 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 10682607660275 [Package] Contains: 00682607660278 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 10682607660282 [Package] Contains: 00682607660285 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 20682607533262 [Package] Contains: 00682607660261 Package: Carton [300 Units] In Commercial Distribution |
| GS1 | 20682607533279 [Package] Contains: 10682607660282 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 20682607533286 [Package] Contains: 10682607660275 Package: Carton [18 Units] In Commercial Distribution |
| GS1 | 20682607533309 [Package] Contains: 10682607533302 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 20682607533316 [Package] Contains: 10682607533319 Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 20682607533323 [Package] Contains: 10682607533326 Package: Carton [6 Units] In Commercial Distribution |
| GS1 | 20682607533330 [Package] Contains: 00682607660261 Package: Carton [48 Units] In Commercial Distribution |
| GS1 | 20682607533347 [Package] Contains: 00682607660278 Package: Carton [48 Units] In Commercial Distribution |
| GS1 | 20682607533354 [Package] Contains: 00682607660285 Package: Carton [36 Units] In Commercial Distribution |
| GS1 | 20682607660265 [Package] Contains: 10682607660268 Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 20682607660272 [Package] Contains: 00682607660278 Package: Carton [210 Units] In Commercial Distribution |
| GS1 | 20682607660289 [Package] Contains: 00682607660285 Package: Carton [120 Units] In Commercial Distribution |
| GS1 | 20682607660470 [Package] Contains: 00682607660476 Package: Carton [24 Units] In Commercial Distribution |
| QYT | Over-the-Counter COVID-19 Antigen 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 | 2026-02-03 |
| Device Publish Date | 2026-01-26 |
| 10682607660268 | Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1) |
| 20682607660470 | Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) |
| 20682607660289 | Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5) |
| 20682607660272 | Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2) |
| 20682607660265 | 1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Tes |