Reagent kit "Enzyme immunoassay test system for the detection of class M antibodies to antigens of the Candida genus" "ELISA-Candida-IgM" according to TU 9398-226-70423725-2016 Composed of: - Immunosorbent - 1 tablet; - control positive sample (K+) - 1 fl. (1.2 ml); - control sample of the "slice" level (K+por) - 1 fl. (1.2 ml); - control negative sample (K-) - 1 fl. (1.2 ml); - solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml); - conjugate - 1 fl. (13 ml); - blocking solution (BR) - 1 fl. (7.5 ml); - indicator solution (RI) - 1 vial. (13 ml); - 25-fold rinsing solution concentrate (PR(x25)) - 2 fl. (40 ml); - Sample dilution solution (PPO) - 1 fl. (15 ml); - stop reagent - 1 fl. (12.5 ml). Accessories: 1. Auxiliary plate for preliminary dilution of samples - 2 pcs. 2. Auxiliary plastic containers - 4 pcs. 3. Disposable tips for automatic pipettes - 16 pcs. 4. Adhesive film for tablets - 4 pcs.
Russia·197190·ECOlab JSC·Registered September 26, 2024·Class 2b- Device Name (English)
- Reagent kit "Enzyme immunoassay test system for the detection of class M antibodies to antigens of the Candida genus" "ELISA-Candida-IgM" according to TU 9398-226-70423725-2016 Composed of: - Immunosorbent - 1 tablet; - control positive sample (K+) - 1 fl. (1.2 ml); - control sample of the "slice" level (K+por) - 1 fl. (1.2 ml); - control negative sample (K-) - 1 fl. (1.2 ml); - solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml); - conjugate - 1 fl. (13 ml); - blocking solution (BR) - 1 fl. (7.5 ml); - indicator solution (RI) - 1 vial. (13 ml); - 25-fold rinsing solution concentrate (PR(x25)) - 2 fl. (40 ml); - Sample dilution solution (PPO) - 1 fl. (15 ml); - stop reagent - 1 fl. (12.5 ml). Accessories: 1. Auxiliary plate for preliminary dilution of samples - 2 pcs. 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 антител класса M к антигенам pода Кандида" "ИФА-Кандида-IgM" по ТУ 9398-226-70423725-2016 в составе: - иммуносорбент - 1 планшет; - контрольный положительный образец (К+) - 1 фл. (1,2 мл); - контрольный образец уровня "среза" (К+пор) - 1 фл. (1,2 мл); - контрольный отрицательный образец (К-) - 1 фл. (1,2 мл); - раствор для предварительного разведения образцов (РПРО) - 1 фл. (15 мл); - конъюгат - 1 фл. (13 мл); - блокирующий раствор (БР) - 1 фл. (7,5 мл); - раствор индикаторный (РИ) - 1 фл. (13 мл); - 25-кратный концентрат промывочного раствора (ПР(х25)) - 2 фл. (по 40 мл); - раствор для разведения образцов (РРО) - 1 фл. (15 мл); - стоп-реагент - 1 фл. (12,5 мл). Принадлежности: 1. Вспомогательный планшет для предварительного разведения образцов - 2 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)
- 197190
- Risk Class
- Class 2b
- OKPD Code
- 20.59.52.195
- Registry Key
- 81929
- Registration Number
- РЗН 2017/6129
- Registration Date
- September 26, 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 class M antibodies to antigens of the Candida genus" "ELISA-Candida-IgM" according to TU 9398-226-70423725-2016 Composed of: - Immunosorbent - 1 tablet; - control positive sample (K+) - 1 fl. (1.2 ml); - control sample of the "slice" level (K+por) - 1 fl. (1.2 ml); - control negative sample (K-) - 1 fl. (1.2 ml); - solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml); - conjugate - 1 fl. (13 ml); - blocking solution (BR) - 1 fl. (7.5 ml); - indicator solution (RI) - 1 vial. (13 ml); - 25-fold rinsing solution concentrate (PR(x25)) - 2 fl. (40 ml); - Sample dilution solution (PPO) - 1 fl. (15 ml); - stop reagent - 1 fl. (12.5 ml). Accessories: 1. Auxiliary plate for preliminary dilution of samples - 2 pcs. 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 2017/6129 and manufactured by ECOlab JSC. The device was registered on September 26, 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.