PATHFAST hs-cTnI-II 301803

GUDID 04987595301803

PHC CORPORATION

Troponin I IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04987595301803
• NIH Device Record Key: cd08c99c-4f96-4915-bd6f-2e5d155243f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATHFAST hs-cTnI-II
• Version Model Number: N/A
• Catalog Number: 301803
• Company DUNS: 716055632
• Company Name: PHC 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987595301803 [Primary]

FDA Product Code

• MMI: Immunoassay Method, Troponin Subunit

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: 2024-05-09
• Device Publish Date: 2024-05-01

Devices Manufactured by PHC CORPORATION

• 04987595301803 - PATHFAST hs-cTnI-II: 2024-05-09
• 04987595301803 - PATHFAST hs-cTnI-II: 2024-05-09
• 04987905300540 - PHCbi: 2020-04-17 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
• 04987905300533 - PHCbi: 2019-11-25 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
• 04987905300120 - Panasonic: 2019-06-11 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
• 04987905300144 - Panasonic: 2019-06-11 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
• 04987905300014 - Panasonic: 2018-12-21 This equipment is designed for low temperature storage of blood and blood products.
• 04987905300021 - Panasonic: 2018-12-21 This equipment is designed for low temperature storage of blood and blood products.
• 04987905300045 - Panasonic: 2018-12-21 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity