| Primary Device ID | 04048474039559 |
| NIH Device Record Key | 7c5b8510-0870-4c9f-bbd4-059eb068f057 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myoglobin ELISA |
| Version Model Number | EIA-3955 |
| Catalog Number | EIA-3955 |
| 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 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 04048474039559 [Primary] |
| DRR | Amplifier And Signal Conditioner, Biopotential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-08 |
| Device Publish Date | 2023-08-31 |
| 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. |
| 04048474041880 - Salivary Estradiol ELISA | 2023-09-11 Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in sali |
| 04048474051001 - α1-Microglobulin ELISA | 2023-09-11 The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine. |
| 04048474051889 - Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA | 2023-09-11 The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against |
| 04048474051896 - Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA | 2023-09-11 The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against |
| 04048474052527 - DRG:HYBRiD.XL® | 2023-09-11 The DRG:HYBRiD-XL® is a fully automated random access analyzer. |