Reagent kit "Enzyme immunoassay test system for the detection of species-specific immunoglobulins of class A to varicella zoster virus" "ELISA - Varicella - IgA", TU 9398-163-70423725-2016 I. Composition: 1. Immunosorbent - 1 tablet. 2. Control positive sample (K+) - 1 vial. (1.2 ml). 3. Control sample of the level of "slice" (K + por) - 1 fl. (1.2 ml). 4. Control negative sample (K-) - 1 fl. (1.2 ml). 5. Conjugate - 1 fl. (13 ml). 6. Solution for diluting samples (PPO) - 1 bottle. (15 ml). 7. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 8. 25-fold concentrate of flushing solution (PR (x25)) - 2 fl. (40 ml each). 9. Indicator solution (RI) - 1 bottle. (13 ml). 10. Stop-reagent - 1 bottle. (12.5 ml). II. Accessories: 1. Auxiliary plate for preliminary dilution of samples (1 pc.). 2. Auxiliary plastic containers (4 pcs.). 3. Disposable tips for automatic pipettes (16 pcs.). 4. Adhesive film for tablets (4 pcs.).
Russia·138130·ECOlab JSC·Registered September 25, 2024·Class 2b- Device Name (English)
- Reagent kit "Enzyme immunoassay test system for the detection of species-specific immunoglobulins of class A to varicella zoster virus" "ELISA - Varicella - IgA", TU 9398-163-70423725-2016 I. Composition: 1. Immunosorbent - 1 tablet. 2. Control positive sample (K+) - 1 vial. (1.2 ml). 3. Control sample of the level of "slice" (K + por) - 1 fl. (1.2 ml). 4. Control negative sample (K-) - 1 fl. (1.2 ml). 5. Conjugate - 1 fl. (13 ml). 6. Solution for diluting samples (PPO) - 1 bottle. (15 ml). 7. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 8. 25-fold concentrate of flushing solution (PR (x25)) - 2 fl. (40 ml each). 9. Indicator solution (RI) - 1 bottle. (13 ml). 10. Stop-reagent - 1 bottle. (12.5 ml). II. Accessories: 1. Auxiliary plate for preliminary dilution of samples (1 pc.). 2. Auxiliary plastic containers (4 pcs.). 3. Disposable tips for automatic pipettes (16 pcs.). 4. Adhesive film for tablets (4 pcs.).
- Device Name (Russian)
- Набор реагентов «Тест-система иммуноферментная для выявления видоспецифических иммуноглобулинов класса A к вирусу ветряной оспы» "ИФА - Ветряная оспа - IgA", ТУ 9398-163-70423725-2016 I. Состав: 1. Иммуносорбент - 1 планшет. 2. Контрольный положительный образец (К+) - 1 фл. (1,2 мл). 3. Контрольный образец уровня "среза" (К+пор) - 1 фл. (1,2 мл). 4. Контрольный отрицательный образец (К-) - 1 фл. (1,2 мл). 5. Конъюгат - 1 фл. (13 мл). 6. Раствор для разведения образцов (РРО) - 1 фл. (15 мл). 7. Раствор для предварительного разведения образцов (РПРО) - 1 фл. (15 мл). 8. 25-кратный концентрат промывочного раствора (ПР(х25)) - 2 фл. (по 40 мл). 9. Раствор индикаторный (РИ) - 1 фл. (13 мл). 10. Стоп-реагент - 1 фл. (12,5 мл). II. Принадлежности: 1. Вспомогательный планшет для предварительного разведения образцов (1 шт.). 2. Вспомогательные пластиковые емкости (4 шт.). 3. Одноразовые наконечники для автоматических пипеток (16 шт.). 4. Клейкая пленка для планшетов (4 шт.).
- Device Type (English)
- N/A
- Device Type (Russian)
- 138130
- Risk Class
- Class 2b
- OKPD Code
- 20.59.52.195
- Registry Key
- 81946
- Registration Number
- РЗН 2017/6461
- Registration Date
- September 25, 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 detection of species-specific immunoglobulins of class A to varicella zoster virus" "ELISA - Varicella - IgA", TU 9398-163-70423725-2016 I. Composition: 1. Immunosorbent - 1 tablet. 2. Control positive sample (K+) - 1 vial. (1.2 ml). 3. Control sample of the level of "slice" (K + por) - 1 fl. (1.2 ml). 4. Control negative sample (K-) - 1 fl. (1.2 ml). 5. Conjugate - 1 fl. (13 ml). 6. Solution for diluting samples (PPO) - 1 bottle. (15 ml). 7. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 8. 25-fold concentrate of flushing solution (PR (x25)) - 2 fl. (40 ml each). 9. Indicator solution (RI) - 1 bottle. (13 ml). 10. Stop-reagent - 1 bottle. (12.5 ml). II. Accessories: 1. Auxiliary plate for preliminary dilution of samples (1 pc.). 2. Auxiliary plastic containers (4 pcs.). 3. Disposable tips for automatic pipettes (16 pcs.). 4. 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 2017/6461 and manufactured by ECOlab JSC. The device was registered on September 25, 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.