FDA.reportPublic FDA data

DASH® Negative Control Swabs Kit

Primary DI
00850063063012
Brand
DASH® Negative Control Swabs Kit
Company
Nuclein, LLC
Model
SG-0010
Catalog number
SG-0010
Device description
DASH® Negative 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
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
00850063063012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063063012008500630630128500630630120850063063012

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063063005DASH® Rapid PCR InstrumentDASH-0002SG-00022025-01-06
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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Primary DI, Brand, Company table
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15420045517059Aptima®Hologic, Inc.PMN2024-12-19
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00852720008077FilmArray BCID2 Control Panel M416MmqciPMN2021-02-18
00852720008053FilmArray Warrior Control Panel M290MmqciPMN2020-11-24
00852720008046FilmArray RP EZ Control Panel M265MmqciPMN2020-01-22
00852720008039FilmArray RP2/RP2plus Control PanelMmqciPMN2019-12-31
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15420045512023Aptima®Hologic, Inc.PMN2019-07-02
15420045512030Aptima®Hologic, Inc.PMN2019-07-02