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

Basic Information

• Brand Name: DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit
• Primary DI: 00850063063029
• Version / Model: SG-0008
• Catalog Number: SG-0008
• Company Name: Nuclein, LLC
• Labeler DUNS: 093432054
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-06
• Public Version: 1
• Public Version Date: 2025-01-14
• Public Version Status: New
• Public Device Record Key: 72d52fc8-8533-4d67-a441-de46d13f86da

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	866.3920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47920	Multiple-genus respiratory virus nucleic acid IVD, control	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850063063029	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241652	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius