Genabio

GUDID 06942468183007

Genabio COVID-19 Rapid Self-Test Kit

Core Technology Co.,Ltd.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06942468183007
• NIH Device Record Key: beadf983-1642-4bf3-9539-e82e290bb2e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genabio
• Version Model Number: BP291-5
• Company DUNS: 724425892
• Company Name: Core Technology Co.,Ltd.
• Device Count: 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942468181676 [Primary]
GS1	06942468181683 [Primary]
GS1	06942468183007 [Unit of Use]
GS1	16942468181673 [Package]; Contains: 06942468181676; Package: Carton [240 Units]; In Commercial Distribution
GS1	16942468181680 [Package]; Contains: 06942468181683; Package: Carton [120 Units]; In Commercial Distribution

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: 2022-09-20
• Device Publish Date: 2022-09-12