StatusFirst™ Tn I card LSC-131-20-00

GUDID 10743816001263

StatusFirst™ Tn I; Quantitative; 20 Test kit; CE

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: 10743816001263
• NIH Device Record Key: a6cc9a30-13f2-4956-a65f-eac4ce797a50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatusFirst™ Tn I card
• Version Model Number: LSC-131-20-00
• Catalog Number: LSC-131-20-00
• 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	10743816001263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963513

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

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