LifeSign® MI Myo/TnI card LSC-210-20-00

GUDID 10743816001294

LifeSign® MI Myo/TnI; 20 Test kit

PRINCETON BIOMEDITECH CORPORATION

Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical Troponin I IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816001294
• NIH Device Record Key: 04203474-0be8-4ea8-a55b-9d953f0ba4af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSign® MI Myo/TnI card
• Version Model Number: LSC-210-20-00
• Catalog Number: LSC-210-20-00
• 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: false

Customer Support Contacts

• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816001294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022946

FDA Product Code

• MMI: Immunoassay Method, Troponin Subunit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-23

Devices Manufactured by PRINCETON BIOMEDITECH CORPORATION

• 10743816001621 - Status™ COVID-19 Antigen Rapid Test for Home Use: 2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit
• 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