| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04987595301803 [Primary] |
| MMI | Immunoassay Method, Troponin Subunit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-09 |
| Device Publish Date | 2024-05-01 |
| 04987595300011 - PATHFAST Sample Diluent 1 | 2025-04-28 |
| 04987595300028 - PATHFAST Sample Diluent 2 | 2025-04-28 |
| 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. |