Nano-Check Influenza+COVID-19 Dual Test
Basic Information
- Brand Name
- Nano-Check Influenza+COVID-19 Dual Test
- Primary DI
- 00895160002847
- Version / Model
- MD8151E
- Company Name
- NANO-DITECH CORPORATION
- Labeler DUNS
- 126544316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-08-08
- Public Version
- 1
- Public Version Date
- 2024-08-16
- Public Version Status
- New
- Public Device Record Key
- f18c3d34-9ad5-4935-b28a-7afb37a80f9f
Device Description
The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | Unknown | N | |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | 866.3328 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64770 | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical | 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 and/or adenoviruses. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10895160002844 | GS1 | ||||
| Primary | 00895160002847 | GS1 |
Customer Contacts
- Phone
- 609-409-3300
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius