| 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 |
| 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 |
| 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 | 2025-12-0925 Test per kit (L03A-R0125):Test Strips in pouch (25), Test Tubes (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1); 25 Test per kit (L03A-R0135): Test Strips in canister (25), Test Tubes (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (2) |
| 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 |
| 20682607200690 - Mission Liquid Urine Controls | 2025-04-25 Liquid Urine Control |
| 20682607200706 - Mission Liquid Urine Controls | 2025-04-25 Liquid Urine Control |
| 00682607630653 - HealthyMe Early Detection Pregnancy Test | 2025-02-10 Early Detection Pregnancy Test |