Nano-Check TM COVID-19 Antigen Test

Basic Information

• Brand Name: Nano-Check TM COVID-19 Antigen Test
• Primary DI: 00895160002786
• Version / Model: MD-8147
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-11-18
• Public Version: 4
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 49073bbf-ad92-44cf-886a-db1a2881beb5

Device Description

An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. 1) Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests in point-of-care settings. 2) Nano-Check™ COVID-19 Antigen At-Home Test is for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown		N
QLW	Covid-19 Test Home Collection Kit Devices	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
65454	SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active
64787	SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10895160002783	GS1
Primary	00895160002786	GS1
Package	20895160002780	GS1	Kit	2	In Commercial Distribution

Customer Contacts

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