Reagent kit for the detection and quantification of hepatitis B virus (HBV) DNA in clinical material by PCR with hybridization-fluorescence detection "HepaEC B-q" TU 21.20.23-349-70423725-2023 Composed of: I. Form 1, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. PCR tablet - 1 pc. 8. Film for PCR plate - 1 pc. 9. Instructions for use - 1 pc. III. Passport. IV. Excel file in electronic form for calculating the concentration of HBV DNA in the test and control samples - 1 pc.
Russia·286800·CJSC "ECOlab"·Registered September 01, 2023·N/A- Device Name (English)
- Reagent kit for the detection and quantification of hepatitis B virus (HBV) DNA in clinical material by PCR with hybridization-fluorescence detection "HepaEC B-q" TU 21.20.23-349-70423725-2023 Composed of: I. Form 1, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. PCR tablet - 1 pc. 8. Film for PCR plate - 1 pc. 9. Instructions for use - 1 pc. III. Passport. IV. Excel file in electronic form for calculating the concentration of HBV DNA in the test and control samples - 1 pc.
- Device Name (Russian)
- Набор реагентов для выявления и количественного определения ДНК вируса гепатита В (HBV) в клиническом материале методом ПЦР с гибридизационно-флуоресцентной детекцией "ГепаЭК В-q" ТУ 21.20.23-349-70423725-2023 в составе: I. Форма 1, в составе: 1. Смесь 1 B-q - 1 пробирка (1,1 мл). 2. Смесь 2 - 1 пробирка (1,1 мл). 3. Положительный контрольный образец (ПКО) - 1 пробирка (0,5 мл). 4. Положительный контрольный образец (ПКО2) - 1 пробирка (0,5 мл). 5. Отрицательный контрольный образец (ОКО) - 1 пробирка (1,0 мл). 6. Внутренний контрольный образец (ВКО) - 1 пробирка (1,0 мл). 7. Инструкция по применению - 1 шт. II. Форма 2, в составе: 1. Смесь 1 B-q - 1 пробирка (1,1 мл). 2. Смесь 2 - 1 пробирка (1,1 мл). 3. Положительный контрольный образец (ПКО) - 1 пробирка (0,5 мл). 4. Положительный контрольный образец (ПКО2) - 1 пробирка (0,5 мл). 5. Отрицательный контрольный образец (ОКО) - 1 пробирка (1,0 мл). 6. Внутренний контрольный образец (ВКО) - 1 пробирка (1,0 мл). 7. Планшет для ПЦР - 1 шт. 8. Пленка для ПЦР-планшета - 1 шт. 9. Инструкция по применению - 1 шт. III. Паспорт. IV. Файл Excel в электронном виде для расчета концентрации ДНК HBV в исследуемых и контрольных образцах - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286800
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 70915.0
- Registration Number
- РЗН 2023/21014
- 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 Reagent kit for the detection and quantification of hepatitis B virus (HBV) DNA in clinical material by PCR with hybridization-fluorescence detection "HepaEC B-q" TU 21.20.23-349-70423725-2023 Composed of: I. Form 1, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. Instructions for use - 1 pc. II. Form 2, consisting of: 1. Mixture 1 B-q - 1 tube (1.1 ml). 2. Mixture 2 - 1 tube (1.1 ml). 3. Positive control sample (PCP) - 1 tube (0.5 ml). 4. Positive control sample (PCO2) - 1 tube (0.5 ml). 5. Negative control sample (CCP) - 1 tube (1.0 ml). 6. Internal control sample (ICP) - 1 tube (1.0 ml). 7. PCR tablet - 1 pc. 8. Film for PCR plate - 1 pc. 9. Instructions for use - 1 pc. III. Passport. IV. Excel file in electronic form for calculating the concentration of HBV DNA in the test and control samples - 1 pc. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2023/21014 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.