Данные о регистрационном удостоверении на Мн-7.1198889-2009
- Помощь в регистрации медицинских изделий в Росздравнадзоре (РУ)
- Внесение изменений в действующее регистрационное удостоверение (ВИРД)
- Разработка всех необходимых документов для регистрации (подготовка регистрационного досье)
- Проведение испытаний (технические, клинические, токсикологические)
Наименование
Реагенты, реактивы для клинических лабораторных исследований: наборы реагентов для определения субстратов:
Производитель
PZ Cormay S.A., ПОЛЬША
Адрес: Wiosenna 22, 05-092 Lomianki, Poland
Производственная площадка
PZ Cormay S.A., ПОЛЬША. Адрес: Marynin 61A; 21-030 Motycz
Заявитель
PZ Cormay S.A., ПОЛЬША
Номер удостоверения
ИМ-7.109218
Рег. номер товара
Мн-7.1198889-2009
Состав
Альбумина:
Liquick Cor-ALBUMIN mini
Liquick Cor-ALBUMIN 30
Liquick Cor-ALBUMIN 60
Liquick Cor-ALBUMIN 500
ACCENT-200 ALBUMIN
ACCENT-300 ALBUMIN
A-400 ALBUMIN
A-800 ALBUMIN
PRESTIGE 24i LQ ALBUMIN
HC-ALBUMIN
OS-ALBUMIN
BIOLIS 50i ALBUMIN
Микроальбумина:
CORMAY MICROALBUMIN 30
CORMAY MICROALBUMIN 60
CORMAY MICROALBUMIN 120
CORMAY MICROALBUMIN 500
ACCENT-200 MICROALBUMIN
ACCENT-300 MICROALBUMIN
A-400 MICROALBUMIN
A-800 MICROALBUMIN
PRESTIGE 24i MICROALBUMIN
HC-MICROALBUMIN
OS-MICROALBUMIN
BIOLIS 50i MICROALBUMIN
Общего белка:
Liquick Cor-TOTAL PROTEIN 30
Liquick Cor-TOTAL PROTEIN 60
Liquick Cor-TOTAL PROTEIN 120
Liquick Cor-TOTAL PROTEIN 500
ACCENT-200 TOTAL PROTEIN
ACCENT-300 TOTAL PROTEIN
A-400 TOTAL PROTEIN
A-800 TOTAL PROTEIN
PRESTIGE 24i LQ TOTAL PROTEIN
HC-TOTAL PROTEIN
OS-TOTAL PROTEIN
BIOLIS 50i TOTAL PROTEIN
Общего белка в моче:
Liquick Cor-URINE PROTEINS 30
Liquick Cor-URINE PROTEINS 60
ACCENT-200 URINE PROTEINS
ACCENT-300 URINE PROTEINS
A-400 URINE PROTEINS
A-800 URINE PROTEINS
PRESTIGE 24i URINE PROTEINS
BIOLIS 50i URINE PROTEINS
Билирубина:
Liquick Cor-BIL DIRECT 30
Liquick Cor-BIL DIRECT 60
Liquick Cor-BIL DIRECT 500
ACCENT-200 BIL DIRECT
ACCENT-300 BIL DIRECT
A-400 BIL DIRECT
A-800 BIL DIRECT
PRESTIGE 24i LQ BIL DIRECT
HC-BIL DIRECT
OS-BIL DIRECT
Liquick Cor-BIL DIRECT MALLOY-EVELYN 30
Liquick Cor-BIL DIRECT MALLOY-EVELYN 60
BIOLIS 50i BIL DIRECT VANAD
Liquick Cor-BIL TOTAL 30
Liquick Cor-BIL TOTAL 60
Liquick Cor-BIL TOTAL 120
Liquick Cor-BIL TOTAL 500
ACCENT-200 BIL TOTAL
ACCENT-300 BIL TOTAL
A-400 BIL TOTAL
A-800 BIL TOTAL
PRESTIGE 24i LQ BIL TOTAL
HC-BIL TOTAL
OS-BIL TOTAL
Liquick Cor-BIL TOTAL MALLOY-EVELYN 30
Liquick Cor-BIL TOTAL MALLOY-EVELYN 60
Liquick Cor-BIL TOTAL MALLOY-EVELYN 120
Liquick Cor-BIL TOTAL MALLOY-EVELYN 500
BIOLIS 50i BIL TOTAL VANAD
Холестерина:
Liquick Cor-CHOL 30
Liquick Cor-CHOL 60
Liquick Cor-CHOL 120
Liquick Cor-CHOL 500
ACCENT-200 CHOL
ACCENT-300 CHOL
A-400 CHOL
A-800 CHOL
PRESTIGE 24i LQ CHOL
HC-CHOL
OS-CHOL
BIOLIS 50i CHOL
Холестерина ЛПНП:
CORMAY LDL DIRECT
CORMAY LDL DIRECT mini
CORMAY LDL DIRECT 30
CORMAY LDL DIRECT 60
CORMAY LDL DIRECT 120
CORMAY LDL DIRECT 500
ACCENT-200 LDL DIRECT
ACCENT-300 LDL DIRECT
A-400 LDL DIRECT
A-800 LDL DIRECT
PRESTIGE 24i LDL DIRECT
HC-LDL DIRECT
OS-LDL DIRECT
BIOLIS 50i LDL DIRECT
Холестерина ЛПВП:
CORMAY HDL
CORMAY HDL 500
CORMAY HDL DIRECT
CORMAY HDL DIRECT mini
CORMAY HDL DIRECT 30
CORMAY HDL DIRECT 60
CORMAY HDL DIRECT 120
CORMAY HDL DIRECT 500
ACCENT-200 HDL DIRECT
ACCENT-300 HDL DIRECT
A-400 HDL DIRECT
A-800 HDL DIRECT
PRESTIGE 24i HDL DIRECT
HC-HDL DIRECT
OS-HDL DIRECT
BIOLIS 50i HDL DIRECT
Желчных кислот:
Liquick Cor-BILE ACIDS 30
Liquick Cor-BILE ACIDS 60
ACCENT-200 BILE ACIDS
ACCENT-300 BILE ACIDS
A-400 BILE ACIDS
A-800 BILE ACIDS
PRESTIGE 24i BILE ACIDS
HC-BILE ACIDS
OS-BILE ACIDS
Креатинина:
Liquick Cor-CREA ENZYMATIC 30
Liquick Cor-CREA ENZYMATIC 60
Liquick Cor-CREA ENZYMATIC 500
ACCENT-200 CREA ENZYMATIC
ACCENT-300 CREA ENZYMATIC
A-400 CREA ENZYMATIC
A-800 CREA ENZYMATIC
PRESTIGE 24i CREA ENZYMATIC
HC-CREA ENZYMATIC
OS-CREA ENZYMATIC
BIOLIS 50i CREA ENZYMATIC
Liquick Cor-CREATININE 30
Liquick Cor-CREATININE 60
Liquick Cor-CREATININE 500
ACCENT-200 CREATININE
ACCENT-300 CREATININE
A-400 CREATININE
PRESTIGE 24i LQ CREATININE
HC-CREATININE
OS-CREATININE
BIOLIS 50i CREATININE
Глюкозы:
Liquick Cor-GLUCOSE mini
Liquick Cor-GLUCOSE 30
Liquick Cor-GLUCOSE 60
Liquick Cor-GLUCOSE 120
Liquick Cor-GLUCOSE 500
ACCENT-200 GLUCOSE
ACCENT-300 GLUCOSE
A-400 GLUCOSE
A-800 GLUCOSE
PRESTIGE 24i LQ GLUCOSE
HC-GLUCOSE
OS-GLUCOSE
BIOLIS 50i GLUCOSE
CORMAY GLUCOSE HEX mini
CORMAY GLUCOSE HEX 30
CORMAY GLUCOSE HEX 60
CORMAY GLUCOSE HEX 120
CORMAY GLUCOSE HEX 500
ACCENT-200 GLUCOSE HEX
ACCENT-300 GLUCOSE HEX
A-400 GLUCOSE HEX
A-800 GLUCOSE HEX
PRESTIGE 24i GLUCOSE HEX
HC-GLUCOSE HEX
OS-GLUCOSE HEX
BIOLIS 50i GLUCOSE HEX
Триглицеридов:
Liquick Cor-TG 30
Liquick Cor-TG 60
Liquick Cor-TG 120
Liquick Cor-TG 500
ACCENT-200 TG
ACCENT-300 TG
A-400 TG
A-800 TG
PRESTIGE 24i LQ TG
HC-TG
OS-TG
BIOLIS 50i TG
Liquick Cor-TG mono 30
Liquick Cor-TG mono 60
Liquick Cor-TG mono 120
Liquick Cor-TG mono 500
ACCENT-200 TG mono
ACCENT-300 TG mono
A-400 TG mono
A-800 TG mono
PRESTIGE 24i LQ TG mono
HC-TG mono
OS-TG mono
BIOLIS 50i TG mono
Мочевины:
Liquick Cor-UREA 30
Liquick Cor-UREA 60
Liquick Cor-UREA 120
Liquick Cor-UREA 500
ACCENT-200 UREA
ACCENT-300 UREA
A-400 UREA
A-800 UREA
PRESTIGE 24i LQ UREA
HC-UREA
OS-UREA
BIOLIS 50i UREA
Мочевой кислоты:
Liquick Cor-UA 30
Liquick Cor-UA 60
Liquick Cor-UA 120
Liquick Cor-UA 500
ACCENT-200 UA
ACCENT-300 UA
A-400 UA
A-800 UA
PRESTIGE 24i LQ UA
HC-UA
OS-UA
BIOLIS 50i UA
Liquick Cor-UA 30 PLUS
Liquick Cor-UA 60 PLUS
Liquick Cor-UA 120 PLUS
Liquick Cor-UA 500 PLUS
ACCENT-200 UA PLUS
ACCENT-300 UA PLUS
A-400 UA PLUS
A-800 UA PLUS
PRESTIGE 24i LQ UA PLUS
Этанола:
CORMAY ETHANOL 30
CORMAY ETHANOL 60
CORMAY ETHANOL 500
ACCENT-200 ETHANOL
ACCENT-300 ETHANOL
A-400 ETHANOL
A-800 ETHANOL
PRESTIGE 24i ETHANOL
HC-ETHANOL
OS-ETHANOL
BIOLIS 50i ETHANOL
Лактата:
Liquick Cor-LACTATE 30
Liquick Cor-LACTATE 60
Liquick Cor-LACTATE 120
Liquick Cor-LACTATE 500
ACCENT-200 LACTATE
ACCENT-300 LACTATE
A-400 LACTATE
A-800 LACTATE
PRESTIGE 24i LACTATE
HC-LACTATE
OS-LACTATE
BIOLIS 50i LACTATE
Иммуноглобулинов:
CORMAY IgA
ACCENT-200 IgA
ACCENT-300 IgA
A-400 IgA
A-800 IgA
PRESTIGE 24i IgA
OS-IgA
BIOLIS 50i IgA
CORMAY IgG
ACCENT-200 IgG
ACCENT-300 IgG
A-400 IgG
A-800 IgG
PRESTIGE 24i IgG
OS-IgG
BIOLIS 50i IgG
CORMAY IgM
ACCENT-200 IgM
ACCENT-300 IgM
A-400 IgM
A-800 IgM
PRESTIGE 24i IgM
OS-IgM
BIOLIS 50i IgM
CORMAY TOTAL IgE
CORMAY TOTAL IgE 500
ACCENT-200 TOTAL IgE
ACCENT-300 TOTAL IgE
A-400 TOTAL IgE
A-800 TOTAL IgE
PRESTIGE 24i TOTAL IgE
OS-TOTAL IgE
Трансферрина:
CORMAY TRANSFERRIN
ACCENT-200 TRANSFERRIN
ACCENT-300 TRANSFERRIN
A-400 TRANSFERRIN
A-800 TRANSFERRIN
PRESTIGE 24i TRANSFERRIN
OS-TRANSFERRIN
BIOLIS 50i TRANSFERRIN
Липопротеина (а):
CORMAY LIPOPROTEIN (a)
CORMAY LIPOPROTEIN (a) 500
ACCENT-200 LIPOPROTEIN (a)
ACCENT-300 LIPOPROTEIN (a)
A-400 LIPOPROTEIN (a)
A-800 LIPOPROTEIN (a)
PRESTIGE 24i LIPOPROTEIN (a)
OS-LIPOPROTEIN (a)
Комплементов:
CORMAY COMPLEMENT C3
ACCENT-200 COMPLEMENT C3
ACCENT-300 COMPLEMENT C3
A-400 COMPLEMENT C3
A-800 COMPLEMENT C3
PRESTIGE 24i COMPLEMENT C3
OS-COMPLEMENT C3
BIOLIS 50i COMPLEMENT C3
CORMAY COMPLEMENT C4
ACCENT-200 COMPLEMENT C4
ACCENT-300 COMPLEMENT C4
A-400 COMPLEMENT C4
A-800 COMPLEMENT C4
PRESTIGE 24i COMPLEMENT C4
OS-COMPLEMENT C4
BIOLIS 50i COMPLEMENT C4
Гаптоглобина:
CORMAY HAPTOGLOBIN
ACCENT-200 HAPTOGLOBIN
ACCENT-300 HAPTOGLOBIN
A-400 HAPTOGLOBIN
A-800 HAPTOGLOBIN
PRESTIGE 24i HAPTOGLOBIN
OS-HAPTOGLOBIN
Церулоплазмина:
CORMAY CERULOPLASMIN
ACCENT-200 CERULOPLASMIN
ACCENT-300 CERULOPLASMIN
A-400 CERULOPLASMIN
A-800 CERULOPLASMIN
PRESTIGE 24i CERULOPLASMIN
OS-CERULOPLASMIN
Фибриногена:
CORMAY FIBRINOGEN
ACCENT-200 FIBRINOGEN
ACCENT-300 FIBRINOGEN
A-400 FIBRINOGEN
A-800 FIBRINOGEN
PRESTIGE 24i FIBRINOGEN
OS-FIBRINOGEN
Альфа 1 кислого гликопротеина:
CORMAY ALPHA 1-GLYCOPROTEIN ACID
ACCENT-200 ALPHA 1-GLYCOPROTEIN ACID
ACCENT-300 ALPHA 1-GLYCOPROTEIN ACID
A-400 ALPHA 1-GLYCOPROTEIN ACID
A-800 ALPHA 1-GLYCOPROTEIN ACID
PRESTIGE 24i ALPHA 1-GLYCOPROTEIN ACID
OS-ALPHA 1-GLYCOPROTEIN ACID
Альфа 1 антитрипсина:
CORMAY ALPHA 1-ANTITRYPSIN
ACCENT-200 ALPHA 1-ANTITRYPSIN
ACCENT-300 ALPHA 1-ANTITRYPSIN
A-400 ALPHA 1-ANTITRYPSIN
A-800 ALPHA 1-ANTITRYPSIN
PRESTIGE 24i ALPHA 1-ANTITRYPSIN
OS-ALPHA 1-ANTITRYPSIN
Антитромбина III:
CORMAY ANTITHROMBIN III
ACCENT-200 ANTITHROMBIN III
ACCENT-300 ANTITHROMBIN III
A-400 ANTITHROMBIN III
A-800 ANTITHROMBIN III
PRESTIGE 24i ANTITHROMBIN III
OS-ANTITHROMBIN III
BIOLIS 50i ANTITHROMBIN III
С-реактивного белка:
CORMAY CRP ULTRA
CORMAY CRP ULTRA 500
ACCENT-200 CRP ULTRA
ACCENT-300 CRP ULTRA
A-400 CRP ULTRA
A-800 CRP ULTRA
PRESTIGE 24i CRP ULTRA
OS-CRP ULTRA
BIOLIS 50i CRP ULTRA
Миоглобина:
CORMAY MYOGLOBIN
CORMAY MYOGLOBIN 500
ACCENT-200 MYOGLOBIN
ACCENT-300 MYOGLOBIN
A-400 MYOGLOBIN
A-800 MYOGLOBIN
PRESTIGE 24i MYOGLOBIN
OS-MYOGLOBIN
Ферритина:
CORMAY FERRITIN
CORMAY FERRITIN 500
ACCENT-200 FERRITIN
ACCENT-300 FERRITIN
A-400 FERRITIN
A-800 FERRITIN
PRESTIGE 24i FERRITIN
OS-FERRITIN
BIOLIS 50i FERRITIN
Микроглобулинов:
CORMAY ALPHA 1-MICROGLOBULIN
CORMAY ALPHA 1-MICROGLOBULIN 500
ACCENT-200 ALPHA 1-MICROGLOBULIN
ACCENT-300 ALPHA 1-MICROGLOBULIN
A-400 ALPHA 1-MICROGLOBULIN
PRESTIGE 24i ALPHA 1-MICROGLOBULIN
OS-ALPHA 1-MICROGLOBULIN
Ревматоидного фактора:
CORMAY RF
CORMAY RF 500
ACCENT-200 RF
ACCENT-300 RF
A-400 RF
A-800 RF
PRESTIGE 24i RF
OS-RF
BIOLIS 50i RF
Антистрептолизина О:
CORMAY ASO
CORMAY ASO 500
ACCENT-200 ASO
ACCENT-300 ASO
A-400 ASO
A-800 ASO
PRESTIGE 24i ASO
OS-ASO
BIOLIS 50i ASO
Гликированного гемоглобина:
CORMAY HbA1c DIRECT 500
HEMOLYSING REAGENT
ACCENT-200 HbA1c DIRECT
ACCENT-300 HbA1c DIRECT
A-400 HbA1c DIRECT
A-800 HbA1c DIRECT
PRESTIGE 24i HbA1c DIRECT
HC-HbA1c DIRECT
OS-HbA1C DIRECT
BIOLIS 50i HbA1C DIRECT
Аполипопротеинов:
CORMAY APOLIPOPROTEIN B
ACCENT-200 APOLIPOPROTEIN B
ACCENT-300 APOLIPOPROTEIN B
A-400 APOLIPOPROTEIN B
A-800 APOLIPOPROTEIN B
PRESTIGE 24i APOLIPOPROTEIN B
OS-APOLIPOPROTEIN B
D димеров:
ACCENT-200 D-DIMER
ACCENT-300 D-DIMER
A-400 D-DIMER
A-800 D-DIMER
PRESTIGE 24i D-DIMER
HC-D-DIMER
OS-D-DIMER
BIOLIS 50i D-DIMER
Цистатина С:
ACCENT-200 CYSTATIN C
ACCENT-300 CYSTATIN C
A-400 CYSTATIN C
A-800 CYSTATIN C
PRESTIGE 24i CYSTATIN C
HC-CYSTATIN C
OS-CYSTATIN C
BIOLIS 50i CYSTATIN C
Прокальцитонина:
A-400 PROCALCITONIN
A-800 PROCALCITONIN
Назначение
В соответствии с инструкцией по использованию
Дата регистрации
2020-12-22 02:10:56
Срок действия
2025-12-22 02:10:56