FDA UDI
In Commercial Distribution
🇺🇸 United States
Flowflex COVID-19 Antigen Home Test
DI: 00682607002306
·
Model: L031-118B5, L031-125M5, L031-125N5, L031-125P5
·
Acon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
24
Pkg Device Count
1
Basic Information
- Brand Name
- Flowflex COVID-19 Antigen Home Test
- Primary DI
- 00682607002306
- Version / Model
- L031-118B5, L031-125M5, L031-125N5, L031-125P5
- Catalog Number
- L031-118B5, L031-125M5, L031-125N5, L031-125P5
- Company Name
- Acon Laboratories, Inc.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-26
- Public Version
- 1
- Public Version Date
- 2026-02-03
- Public Version Status
- New
- Public Device Record Key
- 7d8e24d8-3779-41a2-b45d-264705801062
Device Description
1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L031-125N5): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L031-125P5): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYT | Over-the-Counter COVID-19 Antigen Test | Microbiology | 866.3984 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65454 | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20682607660265 | GS1 | Carton | 24 | In Commercial Distribution | |
| Package | 10682607660268 | GS1 | Inner Pack | 12 | In Commercial Distribution | |
| Package | 00682607660261 | GS1 | Kit Box | 1 | In Commercial Distribution | |
| Primary | 00682607002306 | GS1 | ||||
| Package | 10682607533319 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Package | 00682607660278 | GS1 | Kit Box | 2 | In Commercial Distribution | |
| Package | 10682607533302 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Package | 20682607533279 | GS1 | Carton | 8 | In Commercial Distribution | |
| Package | 10682607660282 | GS1 | Inner Pack | 12 | In Commercial Distribution | |
| Package | 00682607660285 | GS1 | Kit Box | 5 | In Commercial Distribution | |
| Package | 20682607533330 | GS1 | Carton | 48 | In Commercial Distribution | |
| Package | 20682607533262 | GS1 | Carton | 300 | In Commercial Distribution | |
| Package | 10682607533326 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Package | 20682607533286 | GS1 | Carton | 18 | In Commercial Distribution | |
| Package | 10682607660275 | GS1 | Inner Pack | 12 | In Commercial Distribution | |
| Package | 20682607533354 | GS1 | Carton | 36 | In Commercial Distribution | |
| Package | 00682607660476 | GS1 | Kit Box | 25 | In Commercial Distribution | |
| Package | 20682607660289 | GS1 | Carton | 120 | In Commercial Distribution | |
| Package | 20682607660470 | GS1 | Carton | 24 | In Commercial Distribution | |
| Package | 20682607533309 | GS1 | Carton | 8 | In Commercial Distribution | |
| Package | 20682607533347 | GS1 | Carton | 48 | In Commercial Distribution | |
| Package | 20682607660272 | GS1 | Carton | 210 | In Commercial Distribution | |
| Package | 20682607533323 | GS1 | Carton | 6 | In Commercial Distribution | |
| Package | 20682607533316 | GS1 | Carton | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.