A set of control materials "Lidlab Amur Multi-Immuno Control" for quality control of the determination of multiple parameters in human serum and plasma by immunochemiluminescence analysis (ICLA) on the automatic immunochemiluminescete analyzer "Lidlab Amur" for in vitro diagnostics according to TU 21.20.23-205-65614693-2022 Composed of: 1. Freeze-dried control material, level 1, with a low concentration of 2 vials. 2. Freeze-dried control material, level 2, with a high concentration of 2 vials. 3. Instructions for use - 1 pc. 4. Analytical passport - 1 pc.
Russia·199530·LIDKOR LLC·Registered May 29, 2024·Class 2b- Device Name (English)
- A set of control materials "Lidlab Amur Multi-Immuno Control" for quality control of the determination of multiple parameters in human serum and plasma by immunochemiluminescence analysis (ICLA) on the automatic immunochemiluminescete analyzer "Lidlab Amur" for in vitro diagnostics according to TU 21.20.23-205-65614693-2022 Composed of: 1. Freeze-dried control material, level 1, with a low concentration of 2 vials. 2. Freeze-dried control material, level 2, with a high concentration of 2 vials. 3. Instructions for use - 1 pc. 4. Analytical passport - 1 pc.
- Device Name (Russian)
- Набор контрольных материалов "Лидлаб Амур Мульти-Иммуно Контроль" для контроля качества определения множественных показателей в сыворотке и плазме крови человека методом иммунохемилюминесцентного анализа (ИХЛА) на анализаторе автоматическом иммунохемилюминесцетном "Лидлаб Амур" для диагностики in vitro по ТУ 21.20.23-205-65614693-2022 в составе: 1. Лиофилизированный контрольный материал, уровень 1, с низкой концентрацией - 2 флакона. 2. Лиофилизированный контрольный материал, уровень 2, с высокой концентрацией - 2 флакона. 3. Инструкция по применению - 1 шт. 4. Аналитический паспорт - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 199530
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 77457.0
- Registration Number
- РЗН 2024/22772
- Registration Date
- May 29, 2024
- Manufacturer Name (English)
- LIDKOR LLC
- Manufacturer Name (Russian)
- ООО "ЛИДКОР"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. LIDKOR LLC, 15 Krasnodarskaya St., Yekaterinburg, 620033, Sverdlovsk Region, Russia. 2. LIDKOR LLC, 3A, Priborostroiteley St., Dubna, 141981, Moscow Region, Russia.
- Legal Address (Russian)
- 1. ООО "ЛИДКОР", Россия, 620033, Свердловская область, г. Екатеринбург, ул. Краснодарская, д. 15. 2. ООО "ЛИДКОР", Россия, 141981, Московская область, г. Дубна, ул. Приборостроителей, д. 3А.
- Manufacturing Address
- 620102, Россия, Свердловская область, г.о. город Екатеринбург, г. Екатеринбург, ул. Посадская, стр. 23, офис 204
Access comprehensive regulatory information for A set of control materials "Lidlab Amur Multi-Immuno Control" for quality control of the determination of multiple parameters in human serum and plasma by immunochemiluminescence analysis (ICLA) on the automatic immunochemiluminescete analyzer "Lidlab Amur" for in vitro diagnostics according to TU 21.20.23-205-65614693-2022 Composed of: 1. Freeze-dried control material, level 1, with a low concentration of 2 vials. 2. Freeze-dried control material, level 2, with a high concentration of 2 vials. 3. Instructions for use - 1 pc. 4. Analytical passport - 1 pc. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2024/22772 and manufactured by LIDKOR LLC. The device was registered on May 29, 2024.
This page provides complete registration details including device type, manufacturer information, country of origin (Russia), and regulatory compliance data from the official Russia Roszdravnadzor medical device database. Pure Global AI offers free access to Russia's complete medical device registry, helping global MedTech companies navigate Roszdravnadzor regulations efficiently.