Тест-смужки Акку-чек Перформа

Медтехніка та вироби медичного призначення

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Тест-смужки Акку-Чек Перформа

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Кількість в упаковці

��-�� -��® �� (Test-strip Accu-Chek® Performa)

Roche Diabetes Care GmbH

��-��

�� :

� 50

�� *

��	6,72%
ճ�� **	15,27%
ϳ��	0,14%
��	34,66%
��	0,54%
��, ��	42,66%

*̳�� **�� A. calcoaceticus �� E. coli, �� WO 2007/118647

��:

�� �� Accu-Chek Performa (��-�� ) �� -�� , ��-�� -�� , �� -�� -��.��-�� , ��, �� . �� . �� in vitro �� . ��, �� , �� . �� . �� .̳�, �� -�� , �� , ��, �� . �� , �� . �� . �� , �� . ��  �� : ֳ ��-�� , �� -��, �� .*�� -�� -��.*�� �� �� -�� .�� . �� , �� #. �� .��-�� . �� �� , �� .�� , �� . �� ’� �� -�� .�� , �� -�� -�� .�� -�� -��. �� -�� -�� , �� . �� . �� . �� -�� , �� ﳿ. ��  �� . �� . �� -�� , �� . ��  ��, �� -�� -��.�� , �� , � �� , �� . � �� Roche (��) � ��.�� . �� -�� • �� -�� 2–30 °C. �� -��.• �� -�� 8–44 °C.• �� -�� 10–90%. �� -�� , �� .• �� -�� -�� .• ٳ�� -�� -��, �� -�� .• �� -�� -��.• �� -��, �� . ϳ�� -�� . �� -�� -��. ��-�� . �� -�� , �� -�� -�� -��.• �� -�� . ��-�� . ��  ��: �� , �� , �� . �� . �� .�� .1. �� . �� .2. ϳ�� .3. �� -��. �� -�� .4. �� -�� . �� .5. �� .6. �� -��. �� -��, �� ’�� “�� “. �� -��.7. �� -��. ��: �� ’�� L, �� . �� . �� -��. ��  � �� , �� . �� , �� . �� (AST), �� . �� , �� AST �� , �� . �� , �� . �� �� ’� г�� , �� AST (�� ). �� , �� ﳿ.• �� AST �� .• �� AST �� .• �� (�� ). ��  �� , �� , �� 5,6 ��/� (mmol/L) (100 ��/�� (mg/dL))#. �� , �� , �� 2 �� , ��, � �� (��) �� 75 � (g) ��, �� 7,8 ��/� (mmol/L) (140 ��/�� (mg/dL))#. �� , �� , �� 7,0 ��/� (mmol/L) �� (126 ��/�� (mg/dL) �� )#. �� 5,6 �� 6,9 ��/� (mmol/L) (�� 100 �� 125 ��/�� (mg/dL)) �� 쳿 �� (�� )#. �� . �� , �� , �� . �� : �� , �� . �� .�� , �� -�� ̳�� . �� . ��  �� LO, �� 0,6 ��/� (mmol/L) (10 ��/�� (mg/dL)).�� HI, �� 33,3 ��/� (mmol/L) (600 ��/�� (mg/dL)).� �� E-3 ��. �� . ̲� ��Ҳ �� ’� ͳ�� , �� .�� , �� 䳿:• �� -��.• �� , �� .• �� . �� .�� , �� . ��  �� , �� , �� . �� • � �� -�� ’��, �� . �� 㳺�� , �� .• �� . �� . ��, �� , �� .• �� , �� -��.• �� . � �� 2,8 ��/� (mmol/L) (50 ��/�� (mg/dL)). �� , �� . �� , � �� , �� .• �� , �� 30 �� .• �� .• �� , �� , �� : ��, �� . �� , �� .• �� . ��  �� , �� . �� , �� . �� , �� .�� . �� , �� . �� �� . �� , �� , �� -��. �� , �� , �� .• �� >0,83 ��/� (mmol/L) (>15 ��/�� (mg/dL)) �� .• �� 쳿 (��) >20,3 ��/� (mmol/L) (>1800 ��/�� (mg/dL)) �� .• �� , �� >0,17 ��/� (mmol/L) (>3 ��/�� (mg/dL)) �� .• �� N-��, �� >307 ��/� (µmol/L) (>5 ��/�� (mg/dL)) �� . �� N-�� .• � �� , �� . �� : �� , �� , ��, �� 4-�� NYHA �� .• �� 10 �� 65%. �� , �� .• �� 3094 ��. �� 3094 �� . �� : �� (�� -��) �� , �� . �� , �� ID-GCMS. �� ID-GCMS, �� (��), �� NIST. �� , �� , �� -�� , �� NIST (traceable (��)). �� (�� , �� ): 0,6 ��/� (10 ��/��) �� -�� ĳ�� : 0,6–33,3 ��/� (10–600 ��/��) ��’�� : 0,6 �� �� : 5 �� �� :�� 5,55 ��/� (mmol/L) (�� 100 ��/�� (mg/dL))

� �� ±0,28 ��/� (mmol/L) (� �� ±5 ��/�� (mg/dL))	� �� ±0,56 ��/� (mmol/L) (� �� ±10 ��/�� (mg/dL))	� �� ±0,83 ��/� (mmol/L) (� �� ±15 ��/�� (mg/dL))
137/168 (81,5%)	163/168 (97,0%)	167/168 (99,4%)

�� 5,55 ��/� (mmol/L) �� (100 ��/�� (mg/dL) �� )

� �� ±5%	� �� ±10%	� �� ±15%
256/432 (59,3%)	393/432 (91,0%)	428/432 (99,1%)

�� 0,67 ��/� (mmol/L) (12 ��/�� (mmol/L)) �� 29,1 ��/� (mmol/L) (525 ��/�� (mg/dL))

� �� ±0,83 ��/� (mmol/L) �� ±15% (� �� ±15 ��/�� (mmol/L) �� ±15%)

595/600 (99,2%)

��:

��	[��/��]	42,6	89,5	122,4	186,9	313,0
��	[��/�]	2,4	5,0	6,8	10,4	17,4
��	[��/��]	1,7	3,2	6,3	7,2	11,5
��	[��/�]	0,1	0,2	0,2	0,4	0,6
�� [%]		—	—	3,5	3,9	3,7

�� :

��	[��/��]	45,6	118,6	310,6
��	[��/�]	2,5	6,6	17,2
��	[��/��]	1,3	2,7	6,3
��	[��/�]	0,09	0,2	0,3
�� [%]		—	2,3	2,0

�� : ��, � �� , �� 209 �� , �� :• 97,6% �� 5,55 ��/� (�� 100 ��/��) �� ±0,83 ��/� (� �� ±15 ��/��) ��, �� .• 97,0% �� 5,55 ��/� �� (100 ��/�� ) �� ±15% ��, �� . �� : �� -��, �� (�� Q-GDH), �� Acinetobacter calcoaceticus � �� E. coli, �� . � �� , �� . �� . #�� -�� 0 800 300 540 �� ukraine.accu-chek@roche.com. �� : � �� ’��, � 9:00 �� 18:00.

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