Gazelle PathoCatch MGPF25

GUDID 08908016644022

COVID-19 Antigen Fluorescence Immunoassay Kit

MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

• Primary Device ID: 08908016644022
• NIH Device Record Key: 48453e87-2479-4d6e-8799-04aa977f5841
• Commercial Distribution Discontinuation: 2030-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gazelle PathoCatch
• Version Model Number: MGPF25
• Catalog Number: MGPF25
• Company DUNS: 860396703
• Company Name: MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908016644022 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-17
• Device Publish Date: 2021-11-09

Devices Manufactured by MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

• 08908016644039 - CoviSelf: 2022-03-22 COVID-19 Antigen Lateral Flow Test Device.
• 08908016644008 - CoviSelf: 2021-11-19 COVID-19 Antigen Lateral Flow Test Device.
• 08908016644022 - Gazelle PathoCatch: 2021-11-17COVID-19 Antigen Fluorescence Immunoassay Kit
• 08908016644022 - Gazelle PathoCatch: 2021-11-17 COVID-19 Antigen Fluorescence Immunoassay Kit
• 08908016644015 - PathoCatch: 2021-10-21 COVID-19 Antigen Fluorescence Immunoassay Kit