DASH® SARS-CoV-2 & Flu A/B Test Kit
Basic Information
- Brand Name
- DASH® SARS-CoV-2 & Flu A/B Test Kit
- Primary DI
- 00850063063036
- Version / Model
- SG-0006
- Catalog Number
- SG-0006
- Company Name
- Nuclein, LLC
- Labeler DUNS
- 093432054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-06
- Public Version
- 1
- Public Version Date
- 2025-01-14
- Public Version Status
- New
- Public Device Record Key
- a595d2a2-5a23-4bdc-81f1-26d7eeec4e56
Device Description
The DASH SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings. Positive results of a specific target are indicative of the presence of that viral RNA and may not be the definite cause of disease. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Microbiology | 866.3981 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47922 | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly 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 |
|---|---|---|---|---|---|---|
| Primary | 00850063063036 | GS1 |
Customer Contacts
- Phone
- 1-888-992-3274
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241652 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius