nuclein.comDASH® SARS-CoV-2 & Flu A/B Test
Nuclein, LLC
Nuclein, LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014515702 | 3014515702 | Nuclein, LLC | 1 | N | 2026-01-01 | 8305 Cross Park Dr Austin TX US 78754 |
| 3035381641 | 3035381641 | Nuclein, LLC | 1 | N | 2026-01-01 | 500 Center Ridge Dr Ste 400 Austin TX US 78753 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850063063005 | DASH® Rapid PCR Instrument - The DASH® Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. | 1-888-992-3274 | customersupport@nuclein.com |
| 00850063063012 | DASH® Negative Control Swabs Kit - DASH® Negative Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended. | 1-888-992-3274 | customersupport@nuclein.com |
| 00850063063029 | DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit - DASH® SARS-CoV-2 & Flu A/B Positive Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended. | 1-888-992-3274 | customersupport@nuclein.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 335695 | 1456097506 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | QOF | 2024-12-20 |
| 335699 | 1456097506 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | QOF | 2024-12-20 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QOF | 2 | 2024-12-20 |
PMN
GUDID
DASH® Rapid PCR Instrument - The DASH® Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
2025-01-06
DASH® Negative Control Swabs Kit - DASH® Negative Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended.
2025-01-06
DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit - DASH® SARS-CoV-2 & Flu A/B Positive Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended.
2025-01-06
DASH® SARS-CoV-2 & Flu A/B Test Kit - 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.
2025-01-06