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 |