Nano-Check TM COVID-19 Antigen Test

GUDID 10895160002783

An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.

NANO-DITECH CORPORATION

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10895160002783
• NIH Device Record Key: 49073bbf-ad92-44cf-886a-db1a2881beb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-Check TM COVID-19 Antigen Test
• Version Model Number: MD-8147
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002786 [Primary]
GS1	10895160002783 [Unit of Use]
GS1	20895160002780 [Package]; Contains: 00895160002786; Package: Kit [2 Units]; In Commercial Distribution

FDA Product Code

• QMN: Covid-19 Multi-Analyte Antigen Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-11-18

On-Brand Devices [Nano-Check TM COVID-19 Antigen Test]

• 10895160002783: An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid an
• 10895160002868: An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid an