PATHFAST hs-cTnI-II 301803

GUDID 04987595301803

PHC CORPORATION

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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