| Primary Device ID | 04048474017885 |
| NIH Device Record Key | a3a8add2-9e99-4f3c-a197-b95ab7c51e53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Immunoglobulin E (IgE) ELISA |
| Version Model Number | EIA-1788 |
| Catalog Number | EIA-1788 |
| Company DUNS | 317134468 |
| Company Name | DRG Instruments Gesellschaft mit beschränkter Haftung |
| 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 | 973-564-7555 |
| corpoffice@drg-international.com | |
| Phone | 973-564-7555 |
| 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 | 04048474017885 [Primary] |
| DGC | Ige, Antigen, Antiserum, 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 | 2023-08-26 |
| 04048474023855 - Free Triiodothyronine (fT3) ELISA | 2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum. |
| 04048474038019 - Free T3 ELISA | 2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT |
| 04048474053562 - T3 free | 2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine |
| 04048474038477 - Mumps IgM ELISA | 2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser |
| 04048474056976 - T-3 | 2024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3 |
| 04048474029314 - Salivary Progesterone ELISA | 2023-09-11 Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva |
| 04048474030136 - Salivary Testosterone ELISA | 2023-09-11 The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active tes |
| 04048474031409 - Salivary 17-OH Progesterone ELISA | 2023-09-11 An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva. |