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    Abbott Diagnostics Technologies AS

    FDA registration
    Abbott Diagnostics Technologies AS·11 products·🇳🇴 Norway

    Afinion HbA1c

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014654·Hemoglobin A1c test kit. Intended use: For dete...

    Afinion HbA1c Dx

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060012889·Hemoglobin A1c test kit. Intended use: For dete...

    Afinion ACR Control

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014647·ACR Controls for use with theAfinion ACR test. ...

    Alere Afinion™ HbA1c

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060005683·Hemoglobin A1c test kit. Intended use: For dete...

    Afinion™ 2

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014692·Afinion 2 is a compact, fully automated, multi-...

    Afinion ACR

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014630·Albumin/Creatinine ration test kit. Intended us...

    Alere Afinion™ AS100

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060008042·Alere Afinion AS100 Analyzer with Alere Afinion...

    Afinion HbA1c Dx

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014555·Hemoglobin A1c test kit. Intended use: For dete...

    Afinion HbA1c Control

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014661·HbA1x Controls for use with the Afinion HbA1c t...

    Afinion™ 2

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014623·Afinion 2 is a compact, fully automated, multi-...

    Afinion HbA1c Calibration Verification

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060015798·HbA1c Calibration Verification for use with the...

    Alere Afinion™ ACR

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060005744·Albumin/Creatinine Ratio test kit. Intended use...

    Afinion™ 2

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014708·Afinion 2 is a compact, fully automated, multi-...

    Alere Afinion ACR Control

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060006765·ACR Control for use with the Alere Afinion ACR ...

    Afinion™ 2

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014616·Afinion 2 is a compact, fully automated, multi-...

    Afinion HbA1c Calibration Verification

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060014722·HbA1c Calibration Verification for use with the...

    Alere Afinion HbA1c Control

    FDA UDI
    Abbott Diagnostics Technologies AS·07070060006505·HbA1c Contols for use with the Alere Afinion Hb...

    Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Technologies AS·June 10, 2020

    ALERE AFINION AS100 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS TECHNOLOGIES AS·Product code JQT·April 29, 2021