| Primary Device ID | 08305901009155 |
| NIH Device Record Key | 8ea4450e-0c5e-41d0-b4d2-75581d07b432 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ-SHIGELLA One-Step Shigella species Rapid Test |
| Version Model Number | 1009-15 |
| Company DUNS | 067647321 |
| Company Name | BIOMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08305901009155 [Primary] |
| GNB | Antisera, All Types, Shigella Spp. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2020-01-10 |
| 08305901009155 | The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of |
| 00083059100952 | The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of |