FDA.reportPublic FDA data

DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit

Primary DI
00850063063029
Brand
DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit
Company
Nuclein, LLC
Model
SG-0008
Catalog number
SG-0008
Device description
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.
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241652000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063063029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063063029008500630630298500630630290850063063029

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063063005DASH® Rapid PCR InstrumentDASH-0002SG-00022025-01-06
00850063063012DASH® Negative Control Swabs KitSG-0010SG-00102025-01-06
00850063063036DASH® SARS-CoV-2 & Flu A/B Test KitSG-0006SG-00062025-01-06

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Primary DI, Brand, Company table
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00850063063012DASH® Negative Control Swabs KitNuclein, LLCPMN2025-01-06
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30014613340492SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
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00852720008107SPOTFIRE RSP Negative ControlMmqciPMN2023-09-15
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00852720008053FilmArray Warrior Control Panel M290MmqciPMN2020-11-24
00852720008046FilmArray RP EZ Control Panel M265MmqciPMN2020-01-22
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70845357041080QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2018-11-21
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