FDA UDI
In Commercial Distribution
🇺🇸 United States
CareSuperb COVID-19/FluA&B Antigen Combo Home Test
DI: 00850010224381
·
Model: RCUM-00571
·
Access Bio Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CareSuperb COVID-19/FluA&B Antigen Combo Home Test
- Primary DI
- 00850010224381
- Version / Model
- RCUM-00571
- Company Name
- Access Bio Inc.
- Labeler DUNS
- 116671434
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-24
- Public Version
- 1
- Public Version Date
- 2026-01-01
- Public Version Status
- New
- Public Device Record Key
- 7c0a3c3f-58a6-4792-9bda-0757dc18e316
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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 |
|---|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | 866.3987 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66040 | Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. 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 |
|---|---|---|---|---|---|---|
| Primary | 00850010224381 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251604 | 000 |