Identity
- Trade Name
- DASH® Rapid PCR Instrument FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DASH-0002 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SG-0002 FDA UDI
- Primary DI / UDI-DI
- 00850063063005 FDA UDI
- 510(k) Number
- K241652 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care
DASH® Rapid PCR Instrument by Nuclein, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nuclein, LLC
Sources (1)
- FDA UDI 7b92e0ce-5f15-4f75-ac9a-60cea30726af 37 fields · synced Jun 7, 2026