| Primary Device ID | 03607360047590 |
| NIH Device Record Key | c2b72502-dd2d-4f05-ac17-6edc4813f2d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hb AFSA2 CONTROL (5) |
| Version Model Number | 4759 |
| Catalog Number | 4759 |
| Company DUNS | 276801933 |
| Company Name | SEBIA |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03607360047590 [Primary] |
| JCM | Control, Hemoglobin, Abnormal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 03607360012444 - CAPILLARYS 3 DBS | 2024-05-08 INSTRUMENT |
| 03607360025062 - CAPI 3 NEONAT Hb | 2024-05-08 |
| 03607360025635 - CAPI 3 NEONAT HEMOLYSING SOLUTION | 2024-05-08 |
| 03607360025789 - CAPILLARYS 3 DBS MICROPLATES | 2024-05-08 MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES |
| 03607360047576 - CAPI 3 NEONAT Hb AF Control | 2024-05-08 |
| 03607360047927 - Hb AFSC Control | 2024-05-08 |
| 03607360026014 - ANTISERA CAPI 3 IT (10) | 2023-12-07 |
| 03607360026021 - Sample Diluent CAPI 3 IT (10) | 2023-12-07 |