Status™ COVID-19/Flu BSP-511-25

GUDID 10743816001553

Status™ COVID-19/Flu A&B Antigen test kit, 25 tests

PRINCETON BIOMEDITECH CORPORATION

SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816001553
• NIH Device Record Key: fbc24eb4-9f87-4275-bf5c-7796898fb73b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status™ COVID-19/Flu
• Version Model Number: BSP-511-25
• Catalog Number: BSP-511-25
• 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: true
• OTC Over-The-Counter: false

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
• 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
• 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	10743816001553 [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: 2021-02-23
• Device Publish Date: 2021-02-15

Devices Manufactured by PRINCETON BIOMEDITECH CORPORATION

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• 10743816001638 - Status™ COVID-19 Antigen Rapid Test for Home Use: 2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
• 10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use: 2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit
• 10743816000532 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 35 Test kit
• 10743816000556 - Status hCG card: 2023-07-06 Status hCG card; 35 Test kit
• 10743816000563 - Status hCG card: 2023-07-06 Status hCG card; 12 Test sample kit
• 10743816000570 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 35 Test kit; CE
• 10743816000587 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 10 Test kit; CE