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Sebia, Inc.

Last updated May 24, 2026

Part of Sebia

What 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.

Information

Country: US
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Catalogue (74)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Capi 3 Cdt	2509	FDA UDI	Class I	Active
CDT CAPILLARYS CALIBRATORS (2 Levels)	4760	FDA UDI	Class II	Active
Hydragel 15 Hr Amidoblack	4125	FDA UDI	Class I	Active
Capillarys 3 Dbs	1244	FDA UDI	Class II	Active
IT/IF Control	4788	FDA UDI	Class II	Active
CAPI 3 NEONAT Hb AF Control	4757	FDA UDI	Class II	Active
Hb AFSC Control	4792	FDA UDI	Class II	Active
FLC Lambda	5103	FDA UDI	Class II	Active
Sample Diluent CAPI 3 IT (10)	2602	FDA UDI	Class II	Active
Minicap Hemoglobin	2207	FDA UDI	Class II	Active
Hydragel Protein K20 Maxi Kit	3200	FDA UDI	Class I	Active
Capillarys Hemoglobin	2007	FDA UDI	Class II	Active
Hydragel 54 Proteine Maxi Kit	4260	FDA UDI	Class I	Active
Molecular Mass Control (5)	4781	FDA UDI	Class I	Active
FLC Kappa	5102	FDA UDI	Class II	Active
Hydragel 15 Hr Acid Violet	4122	FDA UDI	Class I	Active
Minicap Cdt	2208	FDA UDI	N/A	Active
Tetravalent Cdt Is	2057	FDA UDI	Class I	Active
Normal Control (5)	4785	FDA UDI	Class I	Active
It/If Control	4788	FDA UDI	Class I	Active
Hydragel 15 Lipoprotein(e)	4134	FDA UDI	Class I	Active
Hypergamma Control (20)	4766	FDA UDI	Class I	Active
Hb AFSA2 CONTROL (5)	4759	FDA UDI	Class II	Active
Hb AFSA2 CONTROL (1)	4758	FDA UDI	Class II	Active
HYDRAGEL 15 LIPO + Lp(a)	4124	FDA UDI	Class I	Active
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)	4768	FDA UDI	Class I	Active
Hydragel 7 Hr Acid Violet	4102	FDA UDI	Class I	Active
Normal Control (20)	4786	FDA UDI	Class I	Active
Hydragel 54 B1-B2	4146	FDA UDI	Class I	Active
Hypergamma Control (5)	4787	FDA UDI	Class I	Active
Normal Cdt Control (5 )	4795	FDA UDI	Class I	Active
Antisera Capi 3 It (10)	2601	FDA UDI	Class II	Active
HYDRAGEL 30 LIPO + Lp(a)	4144	FDA UDI	Class I	Active
CAPI 3 NEONAT Hb	2506	FDA UDI	Class II	Active
CDT MINICAP CALIBRATORS ( 2 Levels)	4761	FDA UDI	Class II	Active
Hydragel 15 Proteine	4120	FDA UDI	Class I	Active
HYDRAGEL 7 LIPO + Lp(a)	4104	FDA UDI	Class I	Active
Capillarys Proteine 6	2003	FDA UDI	Class I	Active
Hydragel Proteine K20	3000	FDA UDI	Class I	Active
Hydragel 30 Protein(e)	4140	FDA UDI	Class I	Active
Hydragel 30 B1-B2	4141	FDA UDI	Class I	Active
Minicap Protein(e) 6 Buffer	2243	FDA UDI	Class I	Active
Capillarys Immunotyping	2100	FDA UDI	Class I	Active
Minicap Proteine 6 Maxi Kit	2223	FDA UDI	Class I	Active
HYDRAGEL LIPO + Lp(a) K20	3007	FDA UDI	Class I	Active
Hydragel Proteinurie K20	3004	FDA UDI	Class I	Active
Hydragel 5 Proteinurie	4115	FDA UDI	Class I	Active
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2)	4767	FDA UDI	Class I	Active
CAPILLARYS NEONAT Hb	2006	FDA UDI	N/A	Active
Hydragel 7 B1-B2	4101	FDA UDI	Class I	Active

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