Регистрационное удостоверение Росздравнадзора
МЗ РФ № 2002/851 от 31 октября 2002 года
Номер регистрационного удостоверения
МЗ РФ № 2002/851
Код вида медицинского изделия
Нет данных
На этой странице собраны сведения о регистрационном удостоверении МЗ РФ № 2002/851. Информация предоставлена в структурированном виде: сведения о регистрационной записи, медицинском изделии, заявителе, производителе, производстве и классификационных признаках.
Основные сведения о регистрационном удостоверении МЗ РФ № 2002/851
Номер регистрационного удостоверения
МЗ РФ № 2002/851
Дата выдачи РУ
31 октября 2002 года
Срок действия РУ
31 октября 2007 года
Номер записи в реестре
o63034
Класс потенциального риска
Нет данных
Код ОКПД2
Нет данных
Наименование медицинского изделия
Реагенты для иммуноферментных анализаторовTDx, IMx и AxSYM в составе (см. Приложение на 10 листах)
. Реагенты для анализатора TDx CORTISOL Reagent X SYS CORTISOL Calibrators X SYS CORTISOL Controls TOTAL ESTRIOL Reagent X SYS TOTAL ESTRIOL Calibrators X SYS TOTAL ESTRIOL Controls X SYS FREE ESTRIOL Calibrators FREE ESTRIOL Centrifuge Tubes X SYS FREE ESTRIOL Controls Filter Holders Fetal Lung Maturity II Reagent X SYS Fetal Lung Maturity II Calibrators X SYS Fetal Lung Maturity II Controls Tumor Marker Multiconstituent Control C-Reactive Protein Reagent X SYS C- Reactive Protein Calibrators X SYS C- Reactive Protein Controls X SYS C- Reactive Protein Controls LH DISOPYRAMIDE Reagent X SYS DISOPYRAMIDE Calibrators X SYS DISOPYRAMIDE Controls LIDOCAINE Reagent X SYS LIDOCAINE Calibrators X SYS LIDOCAINE Controls N-ACETYLPROCAINAMIDE Reagent X SYS N-ACETYLPROCAINAMIDE Calibrators X SYS N-ACETYLPROCAINAMIDE Controls PROCAINAMIDE Reagent X SYS PROCAINAMIDE Calibrators X SYS PROCAINAMIDE Controls QUINIDINE Reagent X SYS QUINIDINE Calibrators X SYS QUINIDINE Controls THEOPHYLLINE II Reagent THEOPHYLLINE Calibrators THEOPHYLLINE Controls AMIKACIN Reagent X SYS AMIKACIN Calibrators X SYS AMIKACIN Controls GENTAMICIN Reagent X SYS GENTAMICIN Calibrators X SYS GENTAMICIN Controls NETILMICIN Reagent X SYS NETILMICIN Calibrators X SYS NETILMICIN Controls TOBRAMYCIN Reagent X SYS TOBRAMYCIN Calibrators X SYS TOBRAMYCIN Controls VANCOMYCIN Reagent X SYS VANCOMYCIN Calibrators X SYS VANCOMYCIN Controls CARBAMAZEPINE Reagent X SYS CARBAMAZEPINE Calibrators X SYS CARBAMAZEPINE Controls X SYS FREE CARBAMAZEPINE Calibrators X SYS FREE CARBAMAZEPINE Controls X SYS Multiconstituent Control for Abused Drug Assays ETHOSUXIMIDE Reagent X SYS ETHOSUXIMIDE Calibrators X SYS ETHOSUXIMIDE Controls PHENOBARBITAL II Reagent X SYS PHENOBARBITAL Calibrators X SYS PHENOBARBITAL Controls PHENYTOIN Reagent X SYS PHENYTOIN Calibrators X SYS PHENYTOIN Controls X SYS FREE PHENYTOIN Calibrators X SYS FREE PHENYTOIN Controls PRIMIDONE Reagent X SYS PRIMIDONE Calibrators X SYS PRIMIDONE Controls VALPROIC ACID Reagent X SYS VALPROIC ACID Calibrators X SYS VALPROIC ACID Controls X SYS FREE VALPROIC ACID Calibrators X SYS FREE VALPROIC ACID Controls METHOTREXATE II Reagent X SYS METHOTREXATE II Calibrators X SYS METHOTREXATE II Controls DIGITOXIN Reagent X SYS DIGITOXIN Calibrators X SYS DIGITOXIN Controls DIGOXIN II Reagent X SYS DIGOXIN Calibrators X SYS DIGOXIN Controls X SYS DIGOXIN II Precipitation Reagent CYCLOSPORINE Monoclonal Whole Blood Reagent X SYS CYCLOSPORINE Monoclonal Whole Blood Calibrators X SYS CYCLOSPORINE Monoclonal Whole Blood Controls X SYS Probe Clean — R X SYS CYCLOSPORINE Monoclonal Whole Blood Reagent Accessories Immunosupressant Drug Assays — CYCLOSPORINE and METABOLITES Whole Blood X SYS CYCLOSPORINE and METABOLITES Whole Blood Calibrators X SYS CYCLOSPORINE and METABOLITES Whole Blood Controls X SYS CYCLOSPORINE and METABOLITES Whole Blood Reagent Accessories X SYS Multiconstituent Control ACETAMINOPHEN Reagent X SYS ACETAMINOPHEN Calibrators X SYS ACETAMINOPHEN Controls REA ETHANOL Reagent X SYS REA ETHANOL Calibrators X SYS REA ETHANOL (Serum) Controls X SYS REA ETHANOL Whole Blood Controls SALICYLATE Reagent X SYS SALICYLATE Calibrators X SYS SALICYLATE Controls TRICYCLIC ANTIDEPRESSANTS Reagent X SYS TRICYCLIC ANTIDEPRESSANTS Calibrators X SYS TRICYCLIC ANTIDEPRESSANTS Controls BENZODIAZEPINES Reagent X SYS BENZODIAZEPINES Calibrators X SYS BENZODIAZEPINES Controls AMPHETAMINE/METHAMPHETAMINE II Reagent X SYS AMPHETAMINE/METHAMPHETAMINE II Calibrators X SYS AMPHETAMINE/METHAMPHETAMINE II Controls BARBITURATES II U Reagent X SYS BARBITURATES II U Calibrators X SYS BARBITURATES II U Controls COCAINE METABOLITE Reagent X SYS COCAINE METABOLITE Calibrators X SYS COCAINE METABOLITE Controls CANNABINOIDS Reagent X SYS CANNABINOIDS Calibrators X SYS CANNABINOIDS Controls OPIATES Reagent X SYS OPIATES Calibrators X SYS OPIATES Controls PHENCYCLIDINE II Reagent X SYS PHENCYCLIDINE Calibrators X SYS PHENCYCLIDINE Controls METHADONE Reagent X SYS METHADONE Calibrators X SYS METHADONE Controls PROPOXYPHENE Reagent X SYS PROPOXYPHENE Calibrators X SYS PROPOXYPHENE Controls X SYS Diluent buffer Реагенты для анализатора Imx ESTRADIOL Reagent ESTRADIOL Calibrators ESTRADIOL Controls ESTRADIOL Specimen Diluent T-UPTAKE Reagent T-UPTAKE Calibrators T-UPTAKE Controls Ultrasensitive hTSH II Reagent Ultrasensitive hTSH II Calibrators Ultrasensitive hTSH II Controls Ultrasensitive hTSH II Specimen Diluent Ultrasensitive hTSH II Mode 1 Calibrator FERRITIN Reagent FERRITIN Calibrators FERRITIN Controls INSULIN Reagent INSULIN Calibrators INSULIN Controls GLYCATED Hb Reagent GLYCATED Hb Mode 1 Calibrator GLYCATED Hb Calibrators GLYCATED Hb Controls Rheumatoid Factor Neutralisation Reagent IgE Reagent IgE Calibrators IgE Controls Probe Cleaning Solution Реагенты для анализатора AxSYM T-UPTAKE Reagent T-UPTAKE Standard Calibrators T-UPTAKE Master Calibrators T-UPTAKE Controls FERRITIN Reagent FERRITIN Calibrators FERRITIN Master Calibrators FERRITIN Controls QUINIDINE Reagent QUINIDINE Standard Calibrators QUINIDINE Controls THEOPHYLLINE II Reagent THEOPHYLLINE II Standard Calibrators THEOPHYLLINE II Controls GENTAMICIN Reagent GENTAMICIN Standard Calibrators GENTAMICIN Controls TOBRAMYCIN Reagent TOBRAMYCIN Standard Calibrators TOBRAMYCIN Controls VANCOMYCIN II Reagent VANCOMYCIN II Standard Calibrators VANCOMYCIN II Controls CARBAMAZEPINE Reagent CARBAMAZEPINE Standard Calibrators CARBAMAZEPINE Controls PHENOBARBITAL Reagent PHENOBARBITAL Standard Calibrators PHENOBARBITAL Controls PHENYTOIN Reagent PHENYTOIN Standard Calibrators PHENYTOIN Controls VALPROIC ACID Reagent VALPROIC ACID Standard Calibrators VALPROIC ACID Controls BARBITURATES II U Reagent BARBITURATES II U Master Calibrators BENZODIAZEPINES Reagent BENZODIAZEPINES Master Calibrators BENZODIAZEPINES Standard Calibrators CANNABINOIDS Reagent CANNABINOIDS Master Calibrators COCAINE METABOLITE Reagent COCAINE METABOLITE Master Calibrators OPIATES Reagent OPIATES Master Calibrators AMPHETAMINE/ METAMPHETAMINE II Reagent AMPHETAMINE/ METAMPHETAMINE II Master Calibrators PHENCYCLIDINE (PCP) II Reagent PHENCYCLIDINE (PCP) Master Calibrators METHADONE Reagent METHADONE Master Calibrators ACETAMINOPHEN Reagent ACETAMINOPHEN Master Calibrators ACETAMINOPHEN Controls TRICYCLIC ANTIDEPRESSANTS Reagent TRICYCLIC ANTIDEPRESSANTS Master Calibrators SALICYLATES Reagent SALICYLATES Master Calibrators X SYS Multiconstituent Control for Abused Drug Assays
. Реагенты для анализатора TDx CORTISOL Reagent X SYS CORTISOL Calibrators X SYS CORTISOL Controls TOTAL ESTRIOL Reagent X SYS TOTAL ESTRIOL Calibrators X SYS TOTAL ESTRIOL Controls X SYS FREE ESTRIOL Calibrators FREE ESTRIOL Centrifuge Tubes X SYS FREE ESTRIOL Controls Filter Holders Fetal Lung Maturity II Reagent X SYS Fetal Lung Maturity II Calibrators X SYS Fetal Lung Maturity II Controls Tumor Marker Multiconstituent Control C-Reactive Protein Reagent X SYS C- Reactive Protein Calibrators X SYS C- Reactive Protein Controls X SYS C- Reactive Protein Controls LH DISOPYRAMIDE Reagent X SYS DISOPYRAMIDE Calibrators X SYS DISOPYRAMIDE Controls LIDOCAINE Reagent X SYS LIDOCAINE Calibrators X SYS LIDOCAINE Controls N-ACETYLPROCAINAMIDE Reagent X SYS N-ACETYLPROCAINAMIDE Calibrators X SYS N-ACETYLPROCAINAMIDE Controls PROCAINAMIDE Reagent X SYS PROCAINAMIDE Calibrators X SYS PROCAINAMIDE Controls QUINIDINE Reagent X SYS QUINIDINE Calibrators X SYS QUINIDINE Controls THEOPHYLLINE II Reagent THEOPHYLLINE Calibrators THEOPHYLLINE Controls AMIKACIN Reagent X SYS AMIKACIN Calibrators X SYS AMIKACIN Controls GENTAMICIN Reagent X SYS GENTAMICIN Calibrators X SYS GENTAMICIN Controls NETILMICIN Reagent X SYS NETILMICIN Calibrators X SYS NETILMICIN Controls TOBRAMYCIN Reagent X SYS TOBRAMYCIN Calibrators X SYS TOBRAMYCIN Controls VANCOMYCIN Reagent X SYS VANCOMYCIN Calibrators X SYS VANCOMYCIN Controls CARBAMAZEPINE Reagent X SYS CARBAMAZEPINE Calibrators X SYS CARBAMAZEPINE Controls X SYS FREE CARBAMAZEPINE Calibrators X SYS FREE CARBAMAZEPINE Controls X SYS Multiconstituent Control for Abused Drug Assays ETHOSUXIMIDE Reagent X SYS ETHOSUXIMIDE Calibrators X SYS ETHOSUXIMIDE Controls PHENOBARBITAL II Reagent X SYS PHENOBARBITAL Calibrators X SYS PHENOBARBITAL Controls PHENYTOIN Reagent X SYS PHENYTOIN Calibrators X SYS PHENYTOIN Controls X SYS FREE PHENYTOIN Calibrators X SYS FREE PHENYTOIN Controls PRIMIDONE Reagent X SYS PRIMIDONE Calibrators X SYS PRIMIDONE Controls VALPROIC ACID Reagent X SYS VALPROIC ACID Calibrators X SYS VALPROIC ACID Controls X SYS FREE VALPROIC ACID Calibrators X SYS FREE VALPROIC ACID Controls METHOTREXATE II Reagent X SYS METHOTREXATE II Calibrators X SYS METHOTREXATE II Controls DIGITOXIN Reagent X SYS DIGITOXIN Calibrators X SYS DIGITOXIN Controls DIGOXIN II Reagent X SYS DIGOXIN Calibrators X SYS DIGOXIN Controls X SYS DIGOXIN II Precipitation Reagent CYCLOSPORINE Monoclonal Whole Blood Reagent X SYS CYCLOSPORINE Monoclonal Whole Blood Calibrators X SYS CYCLOSPORINE Monoclonal Whole Blood Controls X SYS Probe Clean — R X SYS CYCLOSPORINE Monoclonal Whole Blood Reagent Accessories Immunosupressant Drug Assays — CYCLOSPORINE and METABOLITES Whole Blood X SYS CYCLOSPORINE and METABOLITES Whole Blood Calibrators X SYS CYCLOSPORINE and METABOLITES Whole Blood Controls X SYS CYCLOSPORINE and METABOLITES Whole Blood Reagent Accessories X SYS Multiconstituent Control ACETAMINOPHEN Reagent X SYS ACETAMINOPHEN Calibrators X SYS ACETAMINOPHEN Controls REA ETHANOL Reagent X SYS REA ETHANOL Calibrators X SYS REA ETHANOL (Serum) Controls X SYS REA ETHANOL Whole Blood Controls SALICYLATE Reagent X SYS SALICYLATE Calibrators X SYS SALICYLATE Controls TRICYCLIC ANTIDEPRESSANTS Reagent X SYS TRICYCLIC ANTIDEPRESSANTS Calibrators X SYS TRICYCLIC ANTIDEPRESSANTS Controls BENZODIAZEPINES Reagent X SYS BENZODIAZEPINES Calibrators X SYS BENZODIAZEPINES Controls AMPHETAMINE/METHAMPHETAMINE II Reagent X SYS AMPHETAMINE/METHAMPHETAMINE II Calibrators X SYS AMPHETAMINE/METHAMPHETAMINE II Controls BARBITURATES II U Reagent X SYS BARBITURATES II U Calibrators X SYS BARBITURATES II U Controls COCAINE METABOLITE Reagent X SYS COCAINE METABOLITE Calibrators X SYS COCAINE METABOLITE Controls CANNABINOIDS Reagent X SYS CANNABINOIDS Calibrators X SYS CANNABINOIDS Controls OPIATES Reagent X SYS OPIATES Calibrators X SYS OPIATES Controls PHENCYCLIDINE II Reagent X SYS PHENCYCLIDINE Calibrators X SYS PHENCYCLIDINE Controls METHADONE Reagent X SYS METHADONE Calibrators X SYS METHADONE Controls PROPOXYPHENE Reagent X SYS PROPOXYPHENE Calibrators X SYS PROPOXYPHENE Controls X SYS Diluent buffer Реагенты для анализатора Imx ESTRADIOL Reagent ESTRADIOL Calibrators ESTRADIOL Controls ESTRADIOL Specimen Diluent T-UPTAKE Reagent T-UPTAKE Calibrators T-UPTAKE Controls Ultrasensitive hTSH II Reagent Ultrasensitive hTSH II Calibrators Ultrasensitive hTSH II Controls Ultrasensitive hTSH II Specimen Diluent Ultrasensitive hTSH II Mode 1 Calibrator FERRITIN Reagent FERRITIN Calibrators FERRITIN Controls INSULIN Reagent INSULIN Calibrators INSULIN Controls GLYCATED Hb Reagent GLYCATED Hb Mode 1 Calibrator GLYCATED Hb Calibrators GLYCATED Hb Controls Rheumatoid Factor Neutralisation Reagent IgE Reagent IgE Calibrators IgE Controls Probe Cleaning Solution Реагенты для анализатора AxSYM T-UPTAKE Reagent T-UPTAKE Standard Calibrators T-UPTAKE Master Calibrators T-UPTAKE Controls FERRITIN Reagent FERRITIN Calibrators FERRITIN Master Calibrators FERRITIN Controls QUINIDINE Reagent QUINIDINE Standard Calibrators QUINIDINE Controls THEOPHYLLINE II Reagent THEOPHYLLINE II Standard Calibrators THEOPHYLLINE II Controls GENTAMICIN Reagent GENTAMICIN Standard Calibrators GENTAMICIN Controls TOBRAMYCIN Reagent TOBRAMYCIN Standard Calibrators TOBRAMYCIN Controls VANCOMYCIN II Reagent VANCOMYCIN II Standard Calibrators VANCOMYCIN II Controls CARBAMAZEPINE Reagent CARBAMAZEPINE Standard Calibrators CARBAMAZEPINE Controls PHENOBARBITAL Reagent PHENOBARBITAL Standard Calibrators PHENOBARBITAL Controls PHENYTOIN Reagent PHENYTOIN Standard Calibrators PHENYTOIN Controls VALPROIC ACID Reagent VALPROIC ACID Standard Calibrators VALPROIC ACID Controls BARBITURATES II U Reagent BARBITURATES II U Master Calibrators BENZODIAZEPINES Reagent BENZODIAZEPINES Master Calibrators BENZODIAZEPINES Standard Calibrators CANNABINOIDS Reagent CANNABINOIDS Master Calibrators COCAINE METABOLITE Reagent COCAINE METABOLITE Master Calibrators OPIATES Reagent OPIATES Master Calibrators AMPHETAMINE/ METAMPHETAMINE II Reagent AMPHETAMINE/ METAMPHETAMINE II Master Calibrators PHENCYCLIDINE (PCP) II Reagent PHENCYCLIDINE (PCP) Master Calibrators METHADONE Reagent METHADONE Master Calibrators ACETAMINOPHEN Reagent ACETAMINOPHEN Master Calibrators ACETAMINOPHEN Controls TRICYCLIC ANTIDEPRESSANTS Reagent TRICYCLIC ANTIDEPRESSANTS Master Calibrators SALICYLATES Reagent SALICYLATES Master Calibrators X SYS Multiconstituent Control for Abused Drug Assays
Информация о заявителе, изготовителе и производстве медицинского изделия
Заявитель, держатель РУ
Нет данных
Адрес заявителя
Нет данных
Юридический адрес заявителя
Нет данных
Производитель
ABBOTT Laboratories, SERADYN Inc.
Юридический адрес изготовителя
США, ФРГ, Япония, Пуэрто Рико
Фактический адрес изготовителя
США, ФРГ, Япония, Пуэрто Рико
Производственная площадка
Нет данных
Информация по коду вида медицинского изделия
Код вида медицинского изделия
Нет данных
Раздел вида МИ
Нет данных
Наименование вида МИ
Нет данных
Классификационные признаки вида МИ
Нет данных
Онлайн-бот для проверки кода вида медизделия
Проверьте код вида по названию, назначению изделия и ключевым словам.
Проверьте маршрут регистрации по коду вида, классу риска и документам.
Проверьте маршрут регистрации по коду вида, классу риска и документам.
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Направьте название изделия, назначение, модельный ряд, инструкцию, фото и данные производителя.
По этим сведениям проверяется код вида, класс риска, состав испытаний и маршрут регистрации.
Подробную информацию о регистрации медицинских изделий в Росздравнадзоре читайте здесь.
По этим сведениям проверяется код вида, класс риска, состав испытаний и маршрут регистрации.
Подробную информацию о регистрации медицинских изделий в Росздравнадзоре читайте здесь.
