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    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan 7 Rapsgatan Plant Uppsala Sweden·Product code LKP·December 28, 2015

    Anti-Sm Antibody, Antigen And Control

    FDA classification
    FDA Class 2 ·Anti-Sm Antibody, Antigen And Control

    Assure Adhesive Kit

    FDA UDI
    RELIANCE ORTHODONTIC PRODUCTS INC·D798AKP0·The Assure Adhesive system is intended for use ...

    SPFM, L.P.

    FDA registration
    SPFM, L.P.·1 product·🇺🇸 United States

    ALKP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KLS-Martin L.P.

    FDA registration
    KLS-Martin L.P.·157 products·🇺🇸 United States

    ENCORE MEDICAL, L.P.

    FDA registration
    ENCORE MEDICAL, L.P.·69 products·🇺🇸 United States

    GALDERMA LABORATORIES, L.P.

    FDA registration
    GALDERMA LABORATORIES, L.P.·4 products·🇺🇸 United States

    LKC TECHNOLOGIES, INC.

    FDA registration
    LKC TECHNOLOGIES, INC.·2 products·🇺🇸 United States

    LAP GMBH LASER APPLIKATIONEN

    FDA registration
    LAP GMBH LASER APPLIKATIONEN·3 products·🇩🇪 Germany

    BioLife Plasma Services L.P.

    FDA registration
    BioLife Plasma Services L.P.·1 product·🇺🇸 United States

    Gerresheimer Peachtree City, L.P.

    FDA registration
    Gerresheimer Peachtree City, L.P.·1 product·🇺🇸 United States

    ROECHLING MEDICAL ROCHESTER L.P.

    FDA registration
    ROECHLING MEDICAL ROCHESTER L.P.·1 product·🇺🇸 United States

    Subdural Electrode

    FDA UDI
    Ad-Tech Medical Instrument Corporation·00841823108371·

    ALKALINE PHOSPHATASE (ALKP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO ALKP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XRS-125-7K-P

    FDA UDI
    SOURCE-RAY, INC.·00868162000210·X-Ray Source Assembly, 125kVp, 7ma / Pulsed

    BKP-10-12.0-15.0

    FDA UDI
    Izi Medical Products, LLC·00815212026669·

    BKP-11-12.0-15.0

    FDA UDI
    Izi Medical Products, LLC·00815212026768·

    I/A/KPE TIP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic