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…
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.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Xiamen Zeesan Biotech Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
| Jiangsu Bioperfectus Technologies Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 3 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
Record
| Listed by | Nuclein, LLC, United States |
|---|---|
| FDA product code | NSU |
| Device type | Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Manufacturer |
| 510(k) | K241652 |
| Record published | 2025-01-06 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 20 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DASH-0002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spartan RX CYP2C19 System | Spartan Bioscience, Inc. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| Aptima® | Hologic, Inc. | 7 |
| OpsisDx | Entopsis, Inc. | 5 |
| Affymetrix | Affymetrix, Inc. | 4 |
| FilmArray® 2.0 Instrument Ngds Configuration | BioFire Defense, LLC | 3 |
| FilmArray® 2.0 Instrument | BioFire Diagnostics, LLC | 3 |
| Opus | Bio-Rad Laboratories Inc. | 3 |
| FilmArray® Torch System Base | BioFire Diagnostics, LLC | 3 |
| FilmArray® Torch Module | BioFire Diagnostics, LLC | 3 |
| Biofire ® Spotfire ® Module | BioFire Diagnostics, LLC | 2 |
| Biofire ® Spotfire ® Control Station | BioFire Diagnostics, LLC | 2 |
Showing 12 of 110. All products under Instrumentation For Clinical Multiplex Test Systems
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Nuclein, LLC | 510(k) number | 2025-10-22 | Not classified | Process control | Due to a software issue | 182 |
| Nuclein, LLC | 510(k) number | 2025-06-25 | Class II | Process control | Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.