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Sign in to claim this brandWhat Sebia, Inc. makes
Sebia, Inc. manufactures in vitro diagnostic (IVD) devices for protein electrophoresis, haemoglobin analysis, and clinical chemistry protein testing. Their products include kits, controls, calibrators, and reagents for detecting and quantifying proteins, haemoglobin subtypes, and transferrin isoforms, often used in diagnostic laboratories for conditions like haemoglobinopathies and liver disease.
The company’s portfolio is regulated under FDA 510(k) and UDI requirements, with devices classified as Class I and Class II. These products are listed in the US under FDA regulatory frameworks, and the manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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Catalogue (74)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Capi 3 Immunotyping | 2600 | FDA UDI | Class I | Active |
| Hydragel 7 Lipoprotein(e) | 4114 | FDA UDI | Class I | Active |
| Capillarys Cdt | 2009 | FDA UDI | Class I | Active |
| High Cdt Control | 4772 | FDA UDI | Class I | Active |
| Capi 3 Proteine 6 | 2503 | FDA UDI | Class I | Active |
| Hydragel 30 Ldl/Hdl Chol Direct | 4139 | FDA UDI | Class I | Active |
| Hydragel 30 Lipoprotein(e) | 4138 | FDA UDI | Class I | Active |
| FLC Control Level 2 | 5113 | FDA UDI | Class II | Active |
| Hydragel 7 Ldl/Hdl Chol Direct | 4116 | FDA UDI | Class I | Active |
| FLC Control Level 1 | 5112 | FDA UDI | Class II | Active |
| Capillarys Protein(e) 6 Buffer | 2043 | FDA UDI | Class I | Active |
| Capillarys Cdt Maxi Kit | 2029 | FDA UDI | Class I | Active |
| Hydragel 7 Proteine | 4100 | FDA UDI | Class I | Active |
| Capi 3 Neonat Hemolysing Solution | 2563 | FDA UDI | Class II | Active |
| Hydragel 15 B1-B2 | 4121 | FDA UDI | Class I | Active |
| Minicap Proteine 6 | 2203 | FDA UDI | Class I | Active |
| Hydragel Hr K20 | 3001 | FDA UDI | Class I | Active |
| Hydragel 54 Proteine | 4145 | FDA UDI | Class I | Active |
| Hydragel 7 Hr Amido Black | 4105 | FDA UDI | Class I | Active |
| Hydragel 15 Ldl/Hdl Chol Direct | 4135 | FDA UDI | Class I | Active |
| A1at Controls (mm-Mz-Ms) | 4771 | FDA UDI | Class I | Active |
| Minicap Cdt Maxi Kit | 2228 | FDA UDI | Class I | Active |
| Capillary's Immunotyping (pn 2100) | K042939 | FDA 510(k) | Class II | Active |
| Capillarys Urine (pn 2012) | K070486 | FDA 510(k) | Class II | Active |
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