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    ARKRAY FACTORY USA, INC.

    FDA registration
    ARKRAY FACTORY USA, INC.·32 products·🇺🇸 United States

    ASSURE PRISM

    FDA Adverse Event
    Injury ·ARKRAY FACTORY USA, INC.·Product code NBW·December 18, 2020

    RELION PRIME TEST STRIPS

    FDA Adverse Event
    Malfunction ·ARKRAY FACTORY USA, INC.·Product code CGA·April 26, 2022

    RELION PRIME GLUCOSE MONITOR

    FDA Adverse Event
    Injury ·ARKRAY FACTORY USA INC.·Product code NBW·April 3, 2019

    TECHLITE PEN NEEDLES

    FDA Adverse Event
    Malfunction ·ARKRAY FACTORY USA, INC.·Product code FMI·September 1, 2022

    RELION PRIME METER AND RELION PRIME BLOOD GLUCOSE TEST STRIPS, 100 COUNT

    FDA Adverse Event
    Malfunction ·ARKRAY FACTORY USA, INC.·Product code NBW·May 5, 2023

    ASSURE ID: SAFETY PEN NEEDLE

    FDA Adverse Event
    Injury ·ARKRAY FACTORY USA, INC.·Product code MEG·July 31, 2019

    ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY FACTORY USA, INC.·Product code NBW·September 14, 2010

    ASSURE PRISM MULTI BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Malfunction ·I-SENS, INC.·Product code NBW·May 1, 2019

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    FDA Adverse Event
    Malfunction ·APEX BIOTECHNOLOGY CORP.·Product code NBW·March 15, 2024

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·APEX BIOTECHNOLOGY CORP.·Product code NBW·June 19, 2023

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    FDA Adverse Event
    Injury ·APEX BIOTECHNOLOGY CORP.·Product code NBW·December 13, 2022

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·APEX BIOTECHNOLOGY CORP.·Product code NBW·March 14, 2025

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·APEX BIOTECHNOLOGY CORP.·Product code NBW·March 14, 2025

    AUTION HYBRID AU-4050

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019

    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015

    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015

    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

    FDA Enforcement
    Class I ·Terminated·Arkray Factory USA, Inc.·January 27, 2016

    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

    FDA Enforcement
    Class I ·Terminated·Arkray Factory USA, Inc.·January 27, 2016

    AUTION HYBRID AU-4050

    FDA Enforcement
    Class II ·Terminated·Arkray Factory USA, Inc.·June 26, 2019