| Primary Device ID | 10682607660268 |
| NIH Device Record Key | 3a494011-27c7-444b-85a1-a0148ec5c8e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flowflex COVID-19 Antigen Home Test |
| Version Model Number | L031-118B5 |
| Catalog Number | 660261 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 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 [Direct Marking] |
| GS1 | 00682607660261 [Primary] |
| GS1 | 10682607660268 [Package] Contains: 00682607660261 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 20682607533262 [Package] Contains: 20682607660265 Package: Carton [300 Units] In Commercial Distribution |
| GS1 | 20682607660265 [Package] Package: Carton [288 Units] In Commercial Distribution |
| QKP | Coronavirus antigen detection test system. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-09 |
| Device Publish Date | 2021-11-01 |
| 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) |