12 results · 43ms · Sources: EU EUDAMED, US FDA

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ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code LCO·July 19, 2019

BIOPHEN UFH Control C1, REF 224101

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

BIOPHEN UFH Control Plasma

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code GGN·June 28, 2022

BIOPHEN UFH Control C2, REF 223901

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

BIOPHEN LMWH Control C4, REF 224201

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code LCO·July 19, 2019

BIOPHEN UFH Control Plasma

FDA Enforcement
Class III ·Terminated·Aniara Diagnostica LLC·September 21, 2022

BIOPHEN LMWH Control C4, REF 224201

FDA Enforcement
Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

BIOPHEN UFH Control C1, REF 224101

FDA Enforcement
Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

BIOPHEN UFH Control C2, REF 223901

FDA Enforcement
Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

FDA Enforcement
Class II ·Terminated·Aniara Diagnostica LLC·August 28, 2019

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

FDA Enforcement
Class II ·Terminated·Aniara Diagnostica LLC·August 28, 2019