| Primary Device ID | 03607360046395 |
| NIH Device Record Key | dae027af-0127-45a9-86b1-363f96a78250 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYDRASHIFT 2 4 daratumumab 20 tests |
| Version Model Number | 4639 |
| Catalog Number | 4639 |
| Company DUNS | 276801933 |
| Company Name | SEBIA |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03607360046395 [Primary] |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2019-07-01 |
| 03607360026014 - ANTISERA CAPI 3 IT (10) | 2023-12-07 |
| 03607360026021 - Sample Diluent CAPI 3 IT (10) | 2023-12-07 |
| 03607360020098 - CAPILLARYS CDT | 2023-09-13 CARBOHYDRATE DEF TRANSFERRING BY CE |
| 03607360020296 - CAPILLARYS CDT MAXI KIT | 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT |
| 03607360022085 - MINICAP CDT | 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE |
| 03607360022283 - MINICAP CDT MAXI KIT | 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE MINICAP |
| 03607360025093 - CAPI 3 CDT | 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE |
| 03607360047583 - Hb AFSA2 CONTROL (1) | 2023-08-04 |