FDA UDI
In Commercial Distribution
🇺🇸 United States
HealthConfirm
DI: 00850041721132
·
Model: CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK
·
CONFIRM BIOSCIENCES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HealthConfirm
- Primary DI
- 00850041721132
- Version / Model
- CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK
- Company Name
- CONFIRM BIOSCIENCES, INC.
- Labeler DUNS
- 806524968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-12
- Public Version
- 1
- Public Version Date
- 2025-09-22
- Public Version Status
- New
- Public Device Record Key
- 5704e85a-7fc3-402b-b489-02606da0f998
Device Description
HealthConfirm Covid/ Flu Combo Test 4 Pack
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 |
|---|---|---|---|---|---|---|
| Package | 20850041721136 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00850041721132 | GS1 |
Customer Contacts
- Phone
- 1-800-908-5603
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240029 | 000 |