| Primary Device ID | 00083059070316 |
| NIH Device Record Key | fa89896f-4b49-4c58-a953-a54d9eba4818 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT |
| Version Model Number | 7031 |
| Company DUNS | 067647321 |
| Company Name | BIOMERICA, INC. |
| 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 |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083059070316 [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 | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
| 00083059070316 | The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human ser |
| 08305900070316 | The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human ser |