LifeSign® MI StatusFirst CK-MB/Myo/TnI card LSC-300-20-02

GUDID 10743816001331

LifeSign® MI StatusFirst CK-MB/Myo/TnI; 20 Test kit; CE

PRINCETON BIOMEDITECH CORPORATION

Troponin I IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816001331
• NIH Device Record Key: 91402d89-91b3-4f70-b9d5-8d916b9d7cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSign® MI StatusFirst CK-MB/Myo/TnI card
• Version Model Number: LSC-300-20-02
• Catalog Number: LSC-300-20-02
• 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	10743816001331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981882

FDA Product Code

• DEA: Myoglobin, Fitc, Antigen, Antiserum, Control

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

On-Brand Devices [LifeSign® MI StatusFirst CK-MB/Myo/TnI card]

• 10743816001348: LifeSign® MI StatusFirst CK-MB/Myo/TnI; 1 Test kit; CE; Multilanguage
• 10743816001331: LifeSign® MI StatusFirst CK-MB/Myo/TnI; 20 Test kit; CE