Reagent kit "Enzyme immunoassay test system for the detection of class M antibodies to Treponema pallidum" "ELISA-antipallidum-IgM PLUS" as per TU 21.20.23-342-70423725-2022 The set is available in 4 basic configurations: The kit includes the following reagents: 1. Set No1/1 - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 2 vials. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 2. Set No1/2: - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Chromogen (TMB) - 1 vial. (2.0 ml); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 2 bottles. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 3. Set No2/1 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 4. Set No2/2 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Chromogen (TMB) - 1 vial. (1.0 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs.
Russia·244340·CJSC "ECOlab"·Registered April 03, 2023·Class 2b- Device Name (English)
- Reagent kit "Enzyme immunoassay test system for the detection of class M antibodies to Treponema pallidum" "ELISA-antipallidum-IgM PLUS" as per TU 21.20.23-342-70423725-2022 The set is available in 4 basic configurations: The kit includes the following reagents: 1. Set No1/1 - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 2 vials. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 2. Set No1/2: - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Chromogen (TMB) - 1 vial. (2.0 ml); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 2 bottles. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 3. Set No2/1 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 4. Set No2/2 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Chromogen (TMB) - 1 vial. (1.0 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs.
- Device Name (Russian)
- Набор реагентов "Тест-система иммуноферментная для выявления антител класса М к Treponema pallidum" "ИФА-антипаллидум-IgM PLUS" по ТУ 21.20.23-342-70423725-2022 Набор выпускается в 4 базовых вариантах комплектации: В состав набора входят следующие реагенты: 1. Комплект №1/1 - Иммуносорбент - 2 планшета; - Контрольный положительный образец (К+) - 1 фл. (0,4 мл); - Контрольный отрицательный образец (К-) - 1 фл. (1,0 мл); - Конъюгат - 2 фл. (по 14 мл); - Раствор для разведения образцов (РРО) - 2 фл. (по 14 мл); - 25-кратный концентрат фосфатно-солевого буферного раствора с твином [ФСБ- Т(х25)] - 2 фл. (по 40 мл); - Раствор индикаторный (РИ) - 2 фл. (по 14 мл); - Стоп-реагент - 1 фл. (25 мл); - Наконечники для автоматических пипеток - 16 шт. Принадлежности: - Вспомогательные пластиковые емкости - 4 шт.; - Клейкая пленка для планшетов - 4 шт. 2. Комплект №1/2: - Иммуносорбент - 2 планшета; - Контрольный положительный образец (К+) - 1 фл. (0,4 мл); - Контрольный отрицательный образец (К-) - 1 фл. (1,0 мл); - Конъюгат - 2 фл. (по 14 мл); - Хромоген (ТМБ) - 1 фл. (2,0 мл); - Раствор для разведения образцов (РРО) - 2 фл. (по 14 мл); - 25-кратный концентрат фосфатно-солевого буферного раствора с твином [ФСБ- Т(х25)] - 2 фл. (по 40 мл); - Цитратный буферный раствор с перекисью водорода (ЦБР) - 2 фл. (по 14 мл); - Стоп-реагент - 1 фл. (25 мл); - Наконечники для автоматических пипеток - 16 шт. Принадлежности: - Вспомогательные пластиковые емкости - 4 шт.; - Клейкая пленка для планшетов - 4 шт. 3. Комплект №2/1 - Иммуносорбент - 1 планшет; - Контрольный положительный образец (К+) - 1 фл. (0,2 мл); - Контрольный отрицательный образец (К-) - 1 фл. (0,5 мл); - Конъюгат - 1 фл. (14 мл); - Раствор для разведения образцов (РРО) - 1 фл. (по 14 мл); - 25-кратный концентрат фосфатно-солевого буферного раствора с твином [ФСБ- Т(х25)] - 2 фл. (по 40 мл); - Раствор индикаторный (РИ) - 1 фл. (14 мл); - Стоп-реагент - 1 фл. (12,5 мл); - Наконечники для автоматических пипеток - 16 шт. Принадлежности: - Вспомогательные пластиковые емкости - 4 шт.; - Клейкая пленка для планшетов - 4 шт. 4. Комплект №2/2 - Иммуносорбент - 1 планшет; - Контрольный положительный образец (К+) - 1 фл. (0,2 мл); - Контрольный отрицательный образец (К-) - 1 фл. (0,5 мл); - Конъюгат - 1 фл. (14 мл); - Хромоген (ТМБ) - 1 фл. (1,0 мл); - Раствор для разведения образцов (РРО) - 1 фл. (по 14 мл); - 25-кратный концентрат фосфатно-солевого буферного раствора с твином [ФСБ- Т(х25)] - 2 фл. (по 40 мл); - Цитратный буферный раствор с перекисью водорода (ЦБР) - 1 фл. (14 мл); - Стоп-реагент - 1 фл. (12,5 мл); - Наконечники для автоматических пипеток - 16 шт. Принадлежности: - Вспомогательные пластиковые емкости - 4 шт.; - Клейкая пленка для планшетов - 4 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 244340
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 69143.0
- Registration Number
- РЗН 2023/19960
- Registration Date
- April 03, 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 detection of class M antibodies to Treponema pallidum" "ELISA-antipallidum-IgM PLUS" as per TU 21.20.23-342-70423725-2022 The set is available in 4 basic configurations: The kit includes the following reagents: 1. Set No1/1 - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 2 vials. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 2. Set No1/2: - Immunosorbent - 2 plates; - Control positive sample (K+) - 1 vial. (0.4 ml); - Control negative sample (K-) - 1 fl. (1.0 ml); - Conjugate - 2 fl. (14 ml each); - Chromogen (TMB) - 1 vial. (2.0 ml); - Sample dilution solution (PPO) - 2 bottles. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 2 bottles. (14 ml each); - Stop reagent - 1 fl. (25 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 3. Set No2/1 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Indicator solution (RI) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 4. Set No2/2 - Immunosorbent - 1 plate; - Control positive sample (K+) - 1 vial. (0.2 ml); - Control negative sample (K-) - 1 fl. (0.5 ml); - Conjugate - 1 fl. (14 ml); - Chromogen (TMB) - 1 vial. (1.0 ml); - Sample dilution solution (PPO) - 1 fl. (14 ml each); - 25-fold concentrate of phosphate-salt buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml); - Citrate buffer solution with hydrogen peroxide (CBR) - 1 bottle. (14 ml); - Stop reagent - 1 fl. (12.5 ml); - Tips for automatic pipettes - 16 pcs. Accessories: - Auxiliary plastic containers - 4 pcs.; - Adhesive film for tablets - 4 pcs. 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 2023/19960 and manufactured by CJSC "ECOlab". The device was registered on April 03, 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.