Sebia

FDA Filings

This page includes the latest FDA filings for Sebia. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Sebia holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number8023024
FEI Number6387
NameKaren Anderson
Owner & OperatorSEBIA
Contact AddressPARC TECHNOLOGIQUE LEONARD DE 27 rue Leonard de VINCI
Lisses-Evry FR-NOTA 91008 FR
Official Correspondent
  • Arnaud - Collin
  • 33-169-898331-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400-1705 Corporate Drive
Norcross, GA 30093 US
Establishment TypeManufacture Medical Device

Registration Number3003961883
FEI Number3003961883
NameINTERLAB S.R.L.
Owner & OperatorSEBIA
Contact AddressPARC TECHNOLOGIQUE LEONARD DE 27 rue Leonard de VINCI
Lisses-Evry FR-NOTA 91008 FR
Official Correspondent
  • Arnaud - Collin
  • 33-169-898331-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVIA RINA MONTI N.26
ROME Lazio, 00155 IT
Establishment TypeManufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
SEBIA
 Hb AFSC Control 47922024-05-08
SEBIA
 CAPI 3 NEONAT Hb AF Control 47572024-05-08
SEBIA
 CAPILLARYS 3 DBS MICROPLATES 25782024-05-08
SEBIA
 CAPI 3 NEONAT HEMOLYSING SOLUTION 25632024-05-08
SEBIA
 CAPI 3 NEONAT Hb 25062024-05-08
SEBIA
 CAPILLARYS 3 DBS 12442024-05-08
SEBIA
 Sample Diluent CAPI 3 IT (10) 26022023-12-07
SEBIA
 ANTISERA CAPI 3 IT (10) 26012023-12-07
SEBIA
 CAPI 3 CDT 25092023-09-13
SEBIA
 MINICAP CDT MAXI KIT 22282023-09-13
SEBIA
 MINICAP CDT 22082023-09-13
SEBIA
 CAPILLARYS CDT MAXI KIT 20292023-09-13
SEBIA
 CAPILLARYS CDT 20092023-09-13
SEBIA
 Hb AFSA2 CONTROL (5) 47592023-08-04
SEBIA
 Hb AFSA2 CONTROL (1) 47582023-08-04
SEBIA
 FLC Control Level 2 51132023-04-10
SEBIA
 FLC Control Level 1 51122023-04-10
SEBIA
 FLC Lambda 51032023-04-10
SEBIA
 FLC Kappa 51022023-04-10
Sebia
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 22022-11-18
SEBIA
 MINICAP HEMOGLOBIN 22072022-06-10
SEBIA
 CAPILLARYS HEMOGLOBIN 20072022-06-10
SEBIA
 CAPILLARYS NEONAT Hb 20062022-06-10
Sebia
HYDRASHIFT 2/4 Isatuximab2021-11-12
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Sebia
CAPI 3 Immunotyping, Capillarys 3 Tera2019-11-01
SEBIA
 HYDRASHIFT 2 4 daratumumab 20 tests 46392019-07-09
Karen Anderson [SEBIA]
HYDRASHIFT 2 /4 daratumumab2019-05-29
Sebia
HYDRASHIFT 2/4 Daratumumab2019-05-02
Karen Anderson [SEBIA]
CAPI 3 HEMOGLOBIN TERA, CAPI 3 HEMOGLOBIN OCTA2018-12-17
SEBIA
CAPI 3 HEMOGLOBIN(E)2018-12-14
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING2018-09-15
Karen Anderson [SEBIA]
HYDRASHIFT 2/4 daratumumab and daratumumab control2018-08-15
Karen Anderson [SEBIA]
HYDRASHIFT 2/4 daratumumab and daratumumab control2018-08-15
Sebia
CAPILLARYS Hb A1c2018-02-07
Sebia
HYDRASHIFT 2/4 Daratumumab, Daratumumab Control2018-01-11
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-11-03
Sebia
CAPI 3 Hb A1c2017-09-12
Karen Anderson [SEBIA]
CAPi3 HbA1c2017-02-21
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-02-21
Karen Anderson [SEBIA]
CAPi3 HbA1c2017-02-21
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-02-21
SEBIA
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)2017-02-17
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Sebia
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL2016-12-21
INTERLAB S.R.L. [SEBIA]
Interlab G26 Electrophoresis System Immunofixation Electrophoresis2016-12-05
INTERLAB S.R.L. [SEBIA]
Interlab G26 Electrophoresis System Immunofixation Electrophoresis2016-12-05
INTERLAB S.R.L. [SEBIA]
Interlab G26 Electrophoresis System Immunofixation Electrophoresis2016-12-05
INTERLAB S.R.L. [SEBIA]
Interlab G26 Electrophoresis System Immunofixation Electrophoresis2016-12-05
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
SEBIA
MINICAP Immunotyping Using The MINICAP And The MINICAP FLEX-PIERCING2015-01-08
SEBIA
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS2014-03-28
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
CAPILLARYS NEONAT HB2013-11-19
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Hemoglobin2013-11-18
SEBIA
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT2013-07-26
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
SEBIA
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C2012-12-06
Karen Anderson [SEBIA]
Capillarys CDT -Capillarys 2 Flex Piercing2012-07-24
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
Capillarys 2 flex piercing- Capillarys Hemoglobin2012-06-07
Karen Anderson [SEBIA]
Capillarys 2- Capillarys Hemoglobin2012-06-07
Karen Anderson [SEBIA]
Capillarys 2 flex piercing- Protein 62012-06-07
SEBIA
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM2012-05-25
SEBIA
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 22012-05-24
SEBIA
IT/IF CONTROL2011-11-07
SEBIA
GELSCAN, MODEL 12062010-08-31
SEBIA
CAPILLARYS NEONAT HB (PN 2006)2010-02-22
SEBIA
MINICAP IMMUNOTYPING, MODEL: 23002009-04-14
SEBIA
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 22272009-03-26
Karen Anderson [SEBIA]
Hydragel Immunofixation2008-07-23
Karen Anderson [SEBIA]
Iso-Pal control2008-07-23
Karen Anderson [SEBIA]
Capillarys Urine2008-07-23
Karen Anderson [SEBIA]
Hydragel 18 A1AT ISOFOCUSING2008-07-23
Karen Anderson [SEBIA]
Hydragel 18 A1AT ISOFOCUSING2008-07-23
Karen Anderson [SEBIA]
Hb AFSC control2008-07-23
Karen Anderson [SEBIA]
Capillarys Hemoglobin(e)2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Normal Control Serum2008-07-23
Karen Anderson [SEBIA]
Hypergamma Control Serum2008-07-23
Karen Anderson [SEBIA]
Hydragel CSF Isofocusing2008-07-23
SEBIA
CAPILLARYS URINE2008-07-01
Karen Anderson [SEBIA]
Hydragel Bence Jones Kit2008-05-13
Karen Anderson [SEBIA]
HYDRAGEL ISO-CK2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL CSF2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ISO-LDH2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ISO-PAL2007-12-18
SEBIA
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)2007-06-11
SEBIA
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)2006-06-27
SEBIA
NORMAL AND HYPERGAMMA CONTROL SERUM2004-04-28
SEBIA
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)2001-06-13
Karen Anderson [SEBIA]
HYDRAGEL LIPOPROTEIN(E)1998-10-26
Karen Anderson [SEBIA]
HYDRAGEL LDL/HDL CHOL Direct1997-06-18
SEBIA
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT1997-03-10
Karen Anderson [SEBIA]
HYDRASYS1996-04-01
SEBIA
HYDRAGEL PROTEIN(E) KIT1995-06-30
Karen Anderson [SEBIA]
HYDRAGEL HR1995-05-24

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NCAGE CodeF5594SEBIA
CAGE CodeF5594SEBIA
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