| Primary Device ID | 00813545025397 |
| NIH Device Record Key | abe9bfb0-688e-47c7-b7e7-f6d3332590c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E.histolytica Antibody 96Tests |
| Version Model Number | EH-96 |
| Catalog Number | EH-96 |
| Company DUNS | 155424708 |
| Company Name | SCIMEDX CORPORATION |
| 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 | true |
| 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 | 18002215598 |
| service@scimedx.com | |
| Phone | 18002215598 |
| service@scimedx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813545025397 [Primary] |
| GWD | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-20 |
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| 00813545029036 - MBO IgG Test System | 2023-06-21 |
| 00813545029043 - PR3 IgG Test System | 2023-06-21 |
| 00813545026561 - MeDiCa | 2020-12-09 Rat Liver 4 Well Slide (each) |
| 00813545026578 - MeDiCa | 2020-12-09 Rat Liver 8 Well Slide (each) |
| 00813545026585 - MeDiCa | 2020-12-09 Crithidia luciliae 4 Well Slide (each) |
| 00813545026592 - MeDiCa | 2020-12-09 Crithidia luciliae 8 Well Slide (each) |