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DASH® SARS-CoV-2 & Flu A/B Test Kit

FDA UDI

Class II (US FDA UDI)

by Nuclein, LLC

Identity

Trade Name
DASH® SARS-CoV-2 & Flu A/B Test Kit FDA UDI
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
SG-0006 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
SG-0006 FDA UDI
Primary DI / UDI-DI
00850063063036 FDA UDI
510(k) Number
K241652 FDA UDI
FDA Product Code
QOF FDA UDI
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3981 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DASH® SARS-CoV-2 & Flu A/B Test Kit by Nuclein, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K241652 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuclein, LLC

Sources (1)

  • FDA UDI a595d2a2-5a23-4bdc-81f1-26d7eeec4e56 37 fields · synced May 30, 2026