| Primary Device ID | 00840239039019 |
| NIH Device Record Key | 9b349c5c-75a1-4e4f-8e49-2ddd78b14a37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENA-6-Profile ELISA |
| Version Model Number | EIA-3901 |
| Catalog Number | EIA-3901 |
| Company DUNS | 075150847 |
| Company Name | DRG International 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9735647555 |
| corpoffice@drg-international.com | |
| Phone | 9735647555 |
| corpoffice@drg-international.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840239039019 [Primary] |
| LLL | Extractable Antinuclear Antibody, Antigen And Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00840239027801 | The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of |
| 00840239039019 | The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class ant |