310 results · 26ms · Sources: EU EUDAMED, US FDA

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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