Ameditech Inc

83 dispositifs dans la base de données

  • Modèle / numéro de série
    G150094 G150136
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, || MTPA-8MBAU || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
  • Modèle / numéro de série
    G140422-C G150059-C G150063-C G150132-C
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), || Item No. TDDA-6MBAU-CUP || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
  • Modèle / numéro de série
    134545 150270 150542 134346 134347 141739 141836 141841 142565 142951 143151 143875 144102 144106 144239 144241 144362 150192 150198 150629 150630 150651 150791 150959 151037 151358 151359 143402 143813 144240 151395 134181 141028 141458 142039 142111 142385 142396 142498 142717 142823 142957 142972 143514 143828 144298 144301 144308 144309 144310 144519 144520 144540 144541 150087 150108 150145 150169 150514 150516 150639 150810 151018 151523 151524 143574 143947 145055 150037 150187 150310 150457 150660 150881 150941 151465 151468 142864 150051 150512 141889 144364 150792 141747 142054 144104 144363 150689 151066 151067 142284 150208 150509 150643 150936 140904 141374 141527 141746 144261 144537 151282 151295 144336 150879 G150042 G140426 G150017 G150048 G150069 G150111 G150146 140905 140906 141014 141027 141225 141228 141347 141440 141446 141510 141740 141742 141751 144334 144335 144539 144545 144546 150148 150154 150168 150232 150462 150478 150601 150602 150653 150808 150938 151283 142514 143150 143404 143858 144394 144440 150482 150513 150904 151372 142528 143154 143405 150339 151297 150050 142529 142971 143155 143474 144547 150286 150654 150786 143803 150003 150207 150828 143874 144562 150182 150231 150325 141296 141372 141475 141476 141583 141842 143825 144227
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; || ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, || PSCupA-10MO, PSCUp-10AB; || ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; || ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, || PSD-10M, PSD-10CMO3, PSD-10APO-300; || ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; || ProScreen 11 Panel Dip Card, Item No. PSD-11MT; || ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; || ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; || ProScreen 12 Panel Dip Card, Item No. PSD-12BUP || ProScreen 5 Panel Dip Card, Item No. PSD-5MB; || ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; || ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; || ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; || ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, || PSD-6MB, PSD-6BUPO; || ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; || ProScreen 8 Panel Dip Card, Item No. PSD-8P; || ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; || ProScreen 9 Panel Dip Card, Item No. PSD-9P; || ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; || ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; || ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; || ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, || PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; || ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
  • Modèle / numéro de série
    141748
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
  • Modèle / numéro de série
    G140435 G140436 G150005 G150016 G150030 G150083 G150125
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Description du dispositif
    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. || ¿¿¿
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  • Adresse du fabricant
    Ameditech Inc, 10340 Camino Santa Fe Ste F, San Diego CA 92121-3104
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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