FDA.report

DASH® Rapid PCR Instrument

Primary DI
00850063063005
Brand
DASH® Rapid PCR Instrument
Company
Nuclein, LLC
Model
DASH-0002
Catalog number
SG-0002
Device 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.
Published
2025-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications

CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions

SubmissionSupplement
K241652000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241652000DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC2024-12-20QOF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850063063005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063063005008500630630058500630630050850063063005

GMDN Terms

TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-992-3274customersupport@nuclein.com

Regulatory Flags

DUNS number
093432054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850063063012DASH® Negative Control Swabs KitSG-0010SG-00102025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitSG-0008SG-00082025-01-06
00850063063036DASH® SARS-CoV-2 & Flu A/B Test KitSG-0006SG-00062025-01-06

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