Reagent kit "Enzyme immunoassay test system for the quantitative determination of autoantibodies to thyroid peroxidase in blood serum (plasma)" "ELISA-at-TPO", according to TU 21.20.23-320-70423725-2022 Composed of: 1. Immunosorbent - 1 plate (12 strips). 2. Calibration samples (KP1-5) - 5 fl. (1.1 ml). 3. Control positive sample (K+) - 1 vial. (1.1 ml). 4. Conjugate - 1 vial. (14 ml). 5. Solution for dilution of the test samples (PPO) - 1 bottle. (50 ml). 6. 26-fold concentrate of washing solution [OR(x26)] - 1 bottle. (22 ml). 7. Indicator solution (RI) - 1 bottle. (14 ml). 8. Stop reagent - 1 bottle. (15 ml). 9. Tips for automatic pipettes - 16 pcs. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Adhesive film for tablets - 4 pcs.
Russia·239180·CJSC "ECOlab"·Registered February 07, 2023·Class 2a- Device Name (English)
- Reagent kit "Enzyme immunoassay test system for the quantitative determination of autoantibodies to thyroid peroxidase in blood serum (plasma)" "ELISA-at-TPO", according to TU 21.20.23-320-70423725-2022 Composed of: 1. Immunosorbent - 1 plate (12 strips). 2. Calibration samples (KP1-5) - 5 fl. (1.1 ml). 3. Control positive sample (K+) - 1 vial. (1.1 ml). 4. Conjugate - 1 vial. (14 ml). 5. Solution for dilution of the test samples (PPO) - 1 bottle. (50 ml). 6. 26-fold concentrate of washing solution [OR(x26)] - 1 bottle. (22 ml). 7. Indicator solution (RI) - 1 bottle. (14 ml). 8. Stop reagent - 1 bottle. (15 ml). 9. Tips for automatic pipettes - 16 pcs. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Adhesive film for tablets - 4 pcs.
- Device Name (Russian)
- Набор реагентов "Тест-система иммуноферментная для количественного определения аутоантител к тиреопероксидазе в сыворотке (плазме) крови" "ИФА-ат-ТПО", по ТУ 21.20.23-320-70423725-2022 в составе: 1. Иммуносорбент - 1 планшет (12 стрипов). 2. Калибровочные пробы (КП1-5) - 5 фл. по (1,1 мл). 3. Контрольный положительный образец (К+) - 1 фл. (1,1 мл). 4. Конъюгат - 1 фл. (14 мл). 5. Раствор для разведения исследуемых образцов (РРО) - 1 фл. (50 мл). 6. 26-кратный концентрат отмывающего раствора [ОР(х26)] - 1 фл. (22 мл). 7. Раствор индикаторный (РИ) - 1 фл. (14 мл). 8. Стоп-реагент - 1 фл. (15 мл). 9. Наконечники для автоматических пипеток - 16 шт. Принадлежности: 1. Вспомогательные пластиковые емкости - 4 шт. 2. Клейкая пленка для планшетов - 4 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 239180
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 68910.0
- Registration Number
- РЗН 2023/19538
- Registration Date
- February 07, 2023
- Manufacturer Name (English)
- CJSC "ECOlab"
- Manufacturer Name (Russian)
- ЗАО "ЭКОлаб"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. ECOlab CJSC, 1 Budennogo St., Elektrogorsk, Moscow Region, 142530, Russia. 2. CJSC "ECOlab", Russia, 142530, Moscow region, Elektrogorsk, Budennogo str., 1 a.
- Legal Address (Russian)
- 1. ЗАО "ЭКОлаб", Россия, 142530, Московская область, г. Электрогорск, ул. Буденного, д. 1. 2. ЗАО "ЭКОлаб", Россия, 142530, Московская область, г. Электрогорск, ул. Буденного, д. 1 а.
- Manufacturing Address
- 142530, Россия, Московская область, г. Электрогорск, ул. Буденного, д. 1
Access comprehensive regulatory information for Reagent kit "Enzyme immunoassay test system for the quantitative determination of autoantibodies to thyroid peroxidase in blood serum (plasma)" "ELISA-at-TPO", according to TU 21.20.23-320-70423725-2022 Composed of: 1. Immunosorbent - 1 plate (12 strips). 2. Calibration samples (KP1-5) - 5 fl. (1.1 ml). 3. Control positive sample (K+) - 1 vial. (1.1 ml). 4. Conjugate - 1 vial. (14 ml). 5. Solution for dilution of the test samples (PPO) - 1 bottle. (50 ml). 6. 26-fold concentrate of washing solution [OR(x26)] - 1 bottle. (22 ml). 7. Indicator solution (RI) - 1 bottle. (14 ml). 8. Stop reagent - 1 bottle. (15 ml). 9. Tips for automatic pipettes - 16 pcs. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Adhesive film for tablets - 4 pcs. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2023/19538 and manufactured by CJSC "ECOlab". The device was registered on February 07, 2023.
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.