BEUDAMED
    17 results · 49ms · Sources: EU EUDAMED, US FDA

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    NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA INTACT PTH CHEMILUMINESCENSE KIT

    FDA Adverse Event
    Injury ·NICHOLS INSTITUTE DIAGNOSTICS·Product code CEW·October 24, 2006

    CALCITONIN CHEMILUMINESCENCE KIT

    FDA Adverse Event
    Injury ·NICHOLS INSTITUTE DIAGNOSTICS·Product code JKR·October 24, 2006

    INTACT PTH, IRMA, 100T

    FDA Adverse Event
    Injury ·NICHOLS INSTITUTE DIAGNOSTICS·Product code CEW·October 24, 2006

    NA INTACT PTH CHEMILUMINESCENSE KIT

    FDA Adverse Event
    Injury ·NICHOLS INSTITUTE DIAGNOSTICS·Product code CEW·October 24, 2006

    NA INTACT PTH CHEMILUMINESCENCSE KIT

    FDA Adverse Event
    Injury ·NICHOLS INSTITUTE DIAGNOSTICS·Product code CEW·October 24, 2006

    ACTH, CHEMILUMINISCENCE KIT

    FDA Adverse Event
    Malfunction ·NICHOLS INSTITUTE DIAGNOSTICS·Product code CKG·October 24, 2006

    Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code MRG·June 30, 2004

    Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·April 14, 2005

    Nichols Advantage TSH - Third Generation

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code JLW·April 28, 2005

    Nichols IRMA Intact PTH Assay, catalog No. 40-2171

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·March 25, 2005

    Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·April 7, 2005

    Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CFL·May 2, 2005

    Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code GGT·September 30, 2005

    Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code DHA·August 31, 2005

    Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code DHA·August 31, 2005

    Nichols Advantage ACTH Test System, catalog number 62-7004.

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CKG·April 22, 2005