Status™ COVID-19 Antigen Rapid Test for Home Use BSP-512-025-00

GUDID 10743816001645

Status™ COVID-19 Antigen for Home Use, 25 Test Kit

PRINCETON BIOMEDITECH CORPORATION

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

• Primary Device ID: 10743816001645
• NIH Device Record Key: 05049f4a-e996-416c-b347-3eb84c607475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status™ COVID-19 Antigen Rapid Test for Home Use
• Version Model Number: BSP-512-25-00
• Catalog Number: BSP-512-025-00
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• 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: false
• 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: true

Customer Support Contacts

• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816001645 [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: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [Status™ COVID-19 Antigen Rapid Test for Home Use]

• 10743816001645: Status™ COVID-19 Antigen for Home Use, 25 Test Kit
• 10743816001638: Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
• 10743816001621: Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit