ARCHITECT Total T3 Reagent Kit

  • Modelo / Serial
    Product List Numbers, Lot Numbers, and Expiration Dates:   1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;  2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.
  • Descripción del producto
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: || - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. || - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. || The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Abbott Ireland Diagnostics Division, Lisnamuck, Co. Longford Ireland
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

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Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    ivd
  • Manufacturer
  • Modelo / Serial
    1) Product Name: ARCHITECT Free T3 Reagent Kit List numbers : 7K63-20, 7K63-25, 7K63-27 2) Product Name: ARCHITECT Total T3 Reagent Kit List Number: 7K64-20, 7K64-25, 7K64-27 Swissmedic Update Code: ARCHITECT Free T3 (FT3) assay Model: 7K63-30/35/32/37 Lot: All Architect Total T3 Reagent Kit Model: 7K64-30/35/32/37 Lot: All
  • Descripción del producto
    IVD, Reagents, Immunoassay
  • Manufacturer
  • Modelo / Serial
    Lot Numbers : 38901UI00, 38901UI01 Expiry 29 January 2015
  • Descripción del producto
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer
4 más