4,033 results · 49ms · Sources: EU EUDAMED, US FDA

CAPI 3 Hb A1c

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CAPILLARYS Hb A1c

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CAPI 3 HEMOGLOBIN(E)

FDA 510(k)
FDA Class 2 ·Hematology

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

FDA 510(k)
FDA Class 2 ·Immunology

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

FDA 510(k)
FDA Class 2 ·Immunology

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS

FDA 510(k)
FDA Class 2 ·Hematology

HYDRASHIFT 2/4 daratumumab

FDA 510(k)
FDA Class 2 ·Immunology

GELSCAN, MODEL 1206

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HYDRASHIFT 2/4 daratumumab, daratumumab Control

FDA 510(k)
FDA Class 2 ·Immunology

HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MINICAP IMMUNOTYPING, MODEL: 2300

FDA 510(k)
FDA Class 2 ·Immunology

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CAPILLARYS URINE (PN 2012)

FDA 510(k)
FDA Class 2 ·Immunology

CAPILLARY'S IMMUNOTYPING (PN 2100)

FDA 510(k)
FDA Class 2 ·Immunology

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·sebia·2 devices

MINICAP Hb A1c

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·sebia·1 device

Hb A1c CAPILLARY CALIBRATORS (2)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·sebia·2 devices

CAPI 3 Hb A1c

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·sebia·1 device

CAPILLARYS Hb A1c

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·sebia·1 device

CAPIprotect

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·sebia·1 device