| Primary Device ID | 04049016151791 |
| NIH Device Record Key | 18af7d83-2bed-4ad6-8173-9556a26a7881 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELISA sample buffer |
| Version Model Number | ZE 1100-10100 |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| 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 | 04049016151791 [Primary] |
| PPM | General Purpose Reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-10 |
| Device Publish Date | 2025-07-02 |
| 04049016139232 - Free Triiodothyronine (FT3) ELISA | 2025-09-22 |
| 04049016151982 - Mounting medium (IIFT) | 2025-07-11 |
| 04049016152002 - Mounting medium (IIFT) | 2025-07-11 |
| 04049016151791 - ELISA sample buffer | 2025-07-10 |
| 04049016151791 - ELISA sample buffer | 2025-07-10 |
| 04049016151838 - ELISA chromogen/substrate solution | 2025-07-10 |
| 04049016151845 - ELISA Stop solution | 2025-07-04 |
| 04049016137986 - EUROLabWorkstation IFA | 2025-06-30 |
| 04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA | 2025-06-30 |