Reagent kit "Enzyme immunoassay test system for the determination of class G immunoglobulins to diphtheria toxoid "ELISA-Diphtheria-IgG" according to TU 21.20.23-367-70423725-2023" Composed of: 1. Immunosorbent - 1 tablet. 2. Calibration samples (KP1, KP2, KP3, KP4, KP5) - 5 vials. (1.5 ml). 3. Control sample (CR) - 1 fl. (1.5 ml). 4. Conjugate - 1 fl (13 ml). 5. Solution for dilution of samples (PPO) - 1 bottle. (15 ml). 6. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 7. 25-fold concentrate of phosphate-saline buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml each). 8. Indicator solution (RI) - 1 bottle. (13 ml). 9. Stop reagent - 1 bottle. (12.5 ml). 10. Flat-bottomed polymer plates for single-use enzyme immunoassay PP-"B-M" as per TU 9393-009-16548645-2005, version: collapsible with a fixative, manufactured by BIOMEDICAL LLC, Russia, RU No FSR 2010/08676 - 1 pc. 11. Universal tip for automatic dispensers according to TU 32.50.50-001-33793949-2019, version version: Universal tip for automatic dispensers with a volume of (0.5 - 250) μl, manufactured by MedLabService LLC, RU No RZN 2021/14326 - 16 pcs. 12. Product for sealing tablets according to TU 32.50.50-009-48072026-2022, design option: adhesive film for tablets with one notch, manufactured by Sovtech Company LLC, Russia, RU No RZN 2022/19122 - 4 pcs. 13. Instructions for use - 1 pc. 14. Passport - 1 pc. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Calibration graph form - 1 pc.
Russia·228850·ECOlab JSC·Registered August 02, 2024·Class 2b- Device Name (English)
- Reagent kit "Enzyme immunoassay test system for the determination of class G immunoglobulins to diphtheria toxoid "ELISA-Diphtheria-IgG" according to TU 21.20.23-367-70423725-2023" Composed of: 1. Immunosorbent - 1 tablet. 2. Calibration samples (KP1, KP2, KP3, KP4, KP5) - 5 vials. (1.5 ml). 3. Control sample (CR) - 1 fl. (1.5 ml). 4. Conjugate - 1 fl (13 ml). 5. Solution for dilution of samples (PPO) - 1 bottle. (15 ml). 6. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 7. 25-fold concentrate of phosphate-saline buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml each). 8. Indicator solution (RI) - 1 bottle. (13 ml). 9. Stop reagent - 1 bottle. (12.5 ml). 10. Flat-bottomed polymer plates for single-use enzyme immunoassay PP-"B-M" as per TU 9393-009-16548645-2005, version: collapsible with a fixative, manufactured by BIOMEDICAL LLC, Russia, RU No FSR 2010/08676 - 1 pc. 11. Universal tip for automatic dispensers according to TU 32.50.50-001-33793949-2019, version version: Universal tip for automatic dispensers with a volume of (0.5 - 250) μl, manufactured by MedLabService LLC, RU No RZN 2021/14326 - 16 pcs. 12. Product for sealing tablets according to TU 32.50.50-009-48072026-2022, design option: adhesive film for tablets with one notch, manufactured by Sovtech Company LLC, Russia, RU No RZN 2022/19122 - 4 pcs. 13. Instructions for use - 1 pc. 14. Passport - 1 pc. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Calibration graph form - 1 pc.
- Device Name (Russian)
- Набор реагентов "Тест-система иммуноферментная для определения иммуноглобулинов класса G к дифтерийному анатоксину "ИФА-Дифтерия-IgG" по ТУ 21.20.23-367-70423725-2023" в составе: 1. Иммуносорбент - 1 планшет. 2. Калибровочные пробы (КП1, КП2, КП3, КП4, КП5) - 5 фл. (по 1,5 мл). 3. Контрольный образец (КО) - 1 фл. (1,5 мл). 4. Конъюгат - 1 фл (13 мл). 5. Раствор для разведения образцов (РРО) - 1 фл. (15 мл). 6. Раствор для предварительного разведения образцов (РПРО) - 1 фл. (15 мл). 7. 25-кратный концентрат фосфатно-солевого буферного раствора с твином [ФСБ-Т(х25)] - 2 фл. (по 40 мл). 8. Раствор индикаторный (РИ) - 1 фл. (13 мл). 9. Стоп-реагент - 1 фл. (12,5 мл). 10. Планшеты полимерные плоскодонные для иммуноферментных исследований однократного применения Пп-"Б-М" по ТУ 9393-009-16548645-2005, вариант исполнения: разборные с фиксатором, производства ООО «БИОМЕДИКАЛ», Россия, РУ № ФСР 2010/08676 - 1 шт. 11. Наконечник универсальный для автоматических дозаторов по ТУ 32.50.50-001-33793949-2019, вариант исполнения: Наконечник универсальный для автоматических дозаторов объемом (0,5 - 250) мкл, производства ООО "МедЛабСервис", РУ № РЗН 2021/14326 - 16 шт. 12. Изделие для запечатывания планшетов по ТУ 32.50.50-009-48072026-2022, вариант исполнения: пленка клейкая для планшетов с одной насечкой, производства ООО "Компания Совтех", Россия, РУ № РЗН 2022/19122 - 4 шт. 13. Инструкция по применению - 1 шт. 14. Паспорт - 1 шт. Принадлежности: 1. Вспомогательные пластиковые емкости - 4 шт. 2. Бланк калибровочного график - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 228850
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 79187.0
- Registration Number
- РЗН 2024/23284
- Registration Date
- August 02, 2024
- Manufacturer Name (English)
- ECOlab JSC
- Manufacturer Name (Russian)
- АО "ЭКОлаб"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- ECOlab JSC, 1a, Budennogo Street, Elektrogorsk, Pavlovo-Posadsky, Moscow Region, 142530, Russia
- Legal Address (Russian)
- АО "ЭКОлаб", Россия, 142530, Московская область, г.о. Павлово - Посадский, г. Электрогорск, ул. Буденного, д. 1а
- Manufacturing Address
- 142530, Россия, Московская область, г.о. Павлово-Посадский, г. Электрогорск, ул. Буденного, д. 1
Access comprehensive regulatory information for Reagent kit "Enzyme immunoassay test system for the determination of class G immunoglobulins to diphtheria toxoid "ELISA-Diphtheria-IgG" according to TU 21.20.23-367-70423725-2023" Composed of: 1. Immunosorbent - 1 tablet. 2. Calibration samples (KP1, KP2, KP3, KP4, KP5) - 5 vials. (1.5 ml). 3. Control sample (CR) - 1 fl. (1.5 ml). 4. Conjugate - 1 fl (13 ml). 5. Solution for dilution of samples (PPO) - 1 bottle. (15 ml). 6. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 7. 25-fold concentrate of phosphate-saline buffer solution with twin [FSB-T(x25)] - 2 bottles. (40 ml each). 8. Indicator solution (RI) - 1 bottle. (13 ml). 9. Stop reagent - 1 bottle. (12.5 ml). 10. Flat-bottomed polymer plates for single-use enzyme immunoassay PP-"B-M" as per TU 9393-009-16548645-2005, version: collapsible with a fixative, manufactured by BIOMEDICAL LLC, Russia, RU No FSR 2010/08676 - 1 pc. 11. Universal tip for automatic dispensers according to TU 32.50.50-001-33793949-2019, version version: Universal tip for automatic dispensers with a volume of (0.5 - 250) μl, manufactured by MedLabService LLC, RU No RZN 2021/14326 - 16 pcs. 12. Product for sealing tablets according to TU 32.50.50-009-48072026-2022, design option: adhesive film for tablets with one notch, manufactured by Sovtech Company LLC, Russia, RU No RZN 2022/19122 - 4 pcs. 13. Instructions for use - 1 pc. 14. Passport - 1 pc. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Calibration graph form - 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 2024/23284 and manufactured by ECOlab JSC. The device was registered on August 02, 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.