310 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
FDA 510(k)
FDA Class 2
·Immunology
QUANTA LITE LKM-1 ELISA
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
FDA 510(k)
FDA Class 2
·Immunology
CA 20:1 L KM
FDA UDI
Bien-Air Dental SA·J00716007850011·CA and HP are intended to transmit and apply th...
Anti-LKM-1 ELISA (IgG)
FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016026808·
QUANTA Lite® LKM- 1 ELISA
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950593201·1. 1x LKM-1 ELISA microwell plate (12-1 x 8 wel...
QUANTA Flash® LKM-1 Reagents
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950767008·1. QUANTA Flash LKM-1 reagent cartridge contain...
QUANTA Flash® Lkm-1 Calibrators
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950766988·1. QUANTA Flash LKM-1 Calibrator 1: Two (2) bar...
QUANTA Flash® LKM-1 Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950766995·1. QUANTA Flash LKM-1 Negative Control: Two (2)...
CA 20:1 LKM Micro-Series
FDA UDI
Bien-Air Dental SA·J00716008740011·CA and HP are intended to transmit and apply th...
CA 20:1 L KM Micro-Series
FDA UDI
Bien-Air Dental SA·J00716007860011·CA and HP are intended to transmit and apply th...
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·December 20, 2024
Set Chiropro L CA 20:1 L KM
FDA UDI
Bien-Air Dental SA·J00717004170011·Sets of Chiropro systems and their dental micro...
Set iChiropro + CA 20:1 L KM MS
FDA UDI
Bien-Air Dental SA·J00717005050011·Sets of Optima systems and their dental micromo...
SET CHIROPRO+ 3rd Gen CA 20:1 L KM
FDA UDI
Bien-Air Dental SA·J00717007380011·Sets of Chiropro systems and their dental micro...
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·December 20, 2024
UF-1000I WITH URINALYSIS WAM
FDA Adverse Event
Malfunction
·SYSMEX·Product code LKM·January 30, 2013
SYSMEX UF-1000I
FDA Adverse Event
SYSMEX AMERICA, INC.·Product code LKM·February 6, 2014
UF1000I
FDA Adverse Event
Other
·SYSMEX 577·Product code LKM·April 11, 2013
UF-1000I WITH URINALYSIS WAM
FDA Adverse Event
Other
·SYSMEX·Product code LKM·April 11, 2013