HepaEC B reagent kit for qualitative detection of hepatitis B virus (HBV) DNA in clinical material by real-time PCR with hybridization-fluorescence detection according to TU 21.20.23-345-70423725-2022 Composed of: I. Form 1, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube (1.0 ml). 5. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube. (1.0 ml). 5. PCR tablet - 1 pc. 6. Film for a PCR tablet - 1 pc. 7. Instructions for use - 1 pc. III. Passport.
Russia·286800·CJSC "ECOlab"·Registered September 01, 2023·N/A- Device Name (English)
- HepaEC B reagent kit for qualitative detection of hepatitis B virus (HBV) DNA in clinical material by real-time PCR with hybridization-fluorescence detection according to TU 21.20.23-345-70423725-2022 Composed of: I. Form 1, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube (1.0 ml). 5. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube. (1.0 ml). 5. PCR tablet - 1 pc. 6. Film for a PCR tablet - 1 pc. 7. Instructions for use - 1 pc. III. Passport.
- Device Name (Russian)
- Набор реагентов "ГепаЭК В" для качественного выявления ДНК вируса гепатита В (HBV) в клиническом материале методом ПЦР с гибридизационно-флуоресцентной детекцией в режиме реального времени по ТУ 21.20.23-345-70423725-2022 в составе: I. Форма 1, в составе: 1. Смесь 1 (В) - 1 пробирка (0,5 мл). 2. Смесь 2 - 1 пробирка (1,5 мл). 3. Положительный контрольный образец (ПКО-В) - 1 пробирка (0,2 мл). 4. Отрицательный контрольный образец (ОКО) - 1 пробирка (1,0 мл). 5. Инструкция по применению - 1 шт. II. Форма 2, в составе: 1. Смесь 1 (В) - 1 пробирка (0,5 мл). 2. Смесь 2 - 1 пробирка (1,5 мл). 3. Положительный контрольный образец (ПКО-В) - 1 пробирка (0,2 мл). 4. Отрицательный контрольный образец (ОКО) - 1 пробирка. (1,0 мл). 5. Планшет для ПЦР - 1 шт. 6. Пленка для ПЦР-планшета - 1 шт. 7. Инструкция по применению - 1 шт. III. Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286800
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 71032.0
- Registration Number
- РЗН 2023/21015
- Registration Date
- September 01, 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 HepaEC B reagent kit for qualitative detection of hepatitis B virus (HBV) DNA in clinical material by real-time PCR with hybridization-fluorescence detection according to TU 21.20.23-345-70423725-2022 Composed of: I. Form 1, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube (1.0 ml). 5. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 (B) - 1 tube (0.5 ml). 2. Mixture 2 - 1 tube (1.5 ml). 3. Positive control sample (PCO-B) - 1 tube (0.2 ml). 4. Negative control sample (CCP) - 1 tube. (1.0 ml). 5. PCR tablet - 1 pc. 6. Film for a PCR tablet - 1 pc. 7. Instructions for use - 1 pc. III. Passport. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2023/21015 and manufactured by CJSC "ECOlab". The device was registered on September 01, 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.