SEBIA

Address:PARC TECHNOLOGIQUE LEONARD DE VINCI,EVRY Essonne,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Immunoelectrophoretic, Immunoglobulins, (G, A, M) (CFF) (4) Assay, Glycosylated Hemoglobin (LCP) (3) Electrophoretic, Protein Fractionation (CEF) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Kappa, Antigen, Antiserum, Control (DFH) (3) Lambda, Antigen, Antiserum, Control (DEH) (3) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Abnormal Hemoglobin Quantitation (GKA) (2) Calibrator, Primary (JIS) (2) Hemoglobin A1c Test System (PDJ) (1)

Premarket Exempt

Clear

CAPILLARYS NEONAT Hb - 03607360020067 Catalog Number : 2006

Device Description : Device used to detect hemoglobin variants using dry blood spots on capillary ele Device used to detect hemoglobin variants using dry blood spots on capillary electrophoresis

Device Class :

Duns Number: 276801933

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

CAPILLARYS HEMOGLOBIN - 03607360020074 Catalog Number : 2007

Device Description : Device that detects and measure hemoglobin variants using capillary electrophoresis

Device Class : 2

Duns Number: 276801933

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

CAPILLARYS Hb A1c - 03607360020159 Catalog Number : 2015

Device Description : Device for the detection and quantitation of HbA1c in whole blood using capillar Device for the detection and quantitation of HbA1c in whole blood using capillary electrophoresis

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : JJX, JIS, LCP

Prescription Use : Yes

Device Count : 1

CAPILLARYS IMMUNOTYPING - 03607360021002 Catalog Number : 2100

Device Description : Device used for the detection and characterization of monoclonal proteins in hum Device used for the detection and characterization of monoclonal proteins in human serum and urine using capillary electrophoresis

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : CEF, DEH, DFH, CFF

Prescription Use : Yes

Device Count : 1

MINICAP HEMOGLOBIN - 03607360022078 Catalog Number : 2207

Device Description : Device used to measure hemoglobin variants

Device Class : 2

Duns Number: 276801933

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

MINICAP Hb A1c - 03607360022153 Catalog Number : 2215

Device Description : Measure HbA1c from whole blood using a Capillary instrument

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : JJX, JIS, LCP

Prescription Use : Yes

Device Count : 1

IT/IF Control - 03607360023006 Catalog Number : 4788

Device Description : Control for the detection and characterization of monoclonal proteins in human s Control for the detection and characterization of monoclonal proteins in human serum and urine

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : DFH, DEH, CFF, CEF, JJY

Prescription Use : Yes

Device Count : 1

CAPI 3 Hb A1c - 03607360025154 Catalog Number : 2515

Device Description : Device intended for measurement of HbA1c in whole blood using capillary electrophoresis

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : JJX, LCP, PDJ

Prescription Use : Yes

Device Count : 1

CAPI 3 IMMUNOTYPING - 03607360026007 Catalog Number : 2600

Device Description : Device designed for the qualitative detection and the characterization of monocl Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis

Device Class : 1

Duns Number: 276801933

Premarket Exempt : No

Product Code : JJY, DFH, DEH, CEF, CFF

Prescription Use : Yes

Device Count : 1

HYDRASHIFT 2 4 daratumumab 20 tests - 03607360046395 Catalog Number : 4639

Device Class : 2

Duns Number: 276801933

Premarket Exempt : No

Product Code : CFF

Prescription Use : Yes

Device Count : 1

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