Reagent kit for detection of DNA of Ureaplasma spp. microorganisms with species differentiation by polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012 For a medical device A set of reagents for the detection of DNA of microorganisms Ureaplasma spp. with differentiation of the species by the polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012, in the following forms of configuration: 1. Sample preparation kit (DNA isolation), including: - reagent in test tubes for DNA isolation from biosamples for subsequent analysis by polymerase chain reaction (DNA-EXPRESS) - 100 tubes of 300 μl each. 2. Reagent kits for PCR amplification: (a) The Endpoint (CT) format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (100 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (100 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (100 μl). b) "Real-Time (RT)" format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (200 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (200 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (200 μl).
Russia·199980·LLC NPF "Litekh"·Registered December 25, 2023·Class 2b- Device Name (English)
- Reagent kit for detection of DNA of Ureaplasma spp. microorganisms with species differentiation by polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012 For a medical device A set of reagents for the detection of DNA of microorganisms Ureaplasma spp. with differentiation of the species by the polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012, in the following forms of configuration: 1. Sample preparation kit (DNA isolation), including: - reagent in test tubes for DNA isolation from biosamples for subsequent analysis by polymerase chain reaction (DNA-EXPRESS) - 100 tubes of 300 μl each. 2. Reagent kits for PCR amplification: (a) The Endpoint (CT) format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (100 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (100 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (100 μl). b) "Real-Time (RT)" format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (200 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (200 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (200 μl).
- Device Name (Russian)
- Набор реагентов для обнаружения ДНК микроорганизмов Ureaplasma spp. c дифференциацией вида методом полимеразной цепной реакции «УРЕАПОЛ» по ТУ 9398-611-17253567-2012 На медицинское изделие Набор реагентов для обнаружения ДНК микроорганизмов Ureaplasma spp. c дифференциацией вида методом полимеразной цепной реакции «УРЕАПОЛ» по ТУ 9398-611-17253567-2012, в следующих формах комплектации: 1. Комплект для пробоподготовки (выделение ДНК), включающий: - реагент в пробирках для выделения ДНК из биопроб с целью последующего анализа методом полимеразной цепной реакции (ДНК-ЭКСПРЕСС) - 100 пробирок по 300 мкл. 2. Комплекты реагентов для проведения ПЦР-амплификации: а) формата «по конечной точке» (КТ) Комплект реагентов для ПЦР выявления Ureaplasma urealyticum, Комплект реагентов для ПЦР выявления Ureaplasma parvum, Комплект реагентов для ПЦР выявления Ureaplasma spp., каждый из которых включает: - реакционную смесь - 1 пробирка (680 мкл); - Taq-полимеразу - 1 пробирка (30 мкл); - разбавитель - 1 пробирка (2 мл); - минеральное масло - 2 пробирки (4 мл); - положительный контрольный образец ДНК - 1 пробирка (100 мкл). Комплект реагентов «Флуороплекс» для ПЦР выявления Ureaplasma spp. с дифференциацией вида, включающий: - реакционную смесь - 1 пробирка (680 мкл); - Taq-полимеразу - 1 пробирка (30 мкл); - разбавитель - 1 пробирка (2 мл); - минеральное масло - 2 пробирки (4 мл); - положительный контрольный образец ДНК Ureaplasma urealyticum - 1 пробирка (100 мкл); - положительный контрольный образец ДНК Ureaplasma parvum - 1 пробирка (100 мкл). б) формата «в Реальном Времени (РВ)» Комплект реагентов для ПЦР выявления Ureaplasma urealyticum, Комплект реагентов для ПЦР выявления Ureaplasma parvum, Комплект реагентов для ПЦР выявления Ureaplasma spp., каждый из которых включает: - реакционную смесь - 1 пробирка (1360 мкл); - Taq-полимеразу - 1 пробирка (60 мкл); - разбавитель - 2 пробирки (4 мл); - минеральное масло - 2 пробирки (4 мл); - положительный контрольный образец ДНК - 1 пробирка (200 мкл). Комплект реагентов «Флуороплекс» для ПЦР выявления Ureaplasma spp. с дифференциацией вида, включающий: - реакционную смесь - 1 пробирка (1360 мкл); - Taq-полимеразу - 1 пробирка (60 мкл); - разбавитель - 2 пробирки (4 мл); - минеральное масло - 2 пробирки (4 мл); - положительный контрольный образец ДНК Ureaplasma urealyticum - 1 пробирка (200 мкл); - положительный контрольный образец ДНК Ureaplasma parvum - 1 пробирка (200 мкл).
- Device Type (English)
- N/A
- Device Type (Russian)
- 199980
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 75867.0
- Registration Number
- ФСР 2012/13814
- Registration Date
- December 25, 2023
- Manufacturer Name (English)
- LLC NPF "Litekh"
- Manufacturer Name (Russian)
- ООО НПФ "Литех"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NPF Litech LLC, 11 Pererva str., bldg. 29, Moscow, 109651, Russia
- Legal Address (Russian)
- ООО НПФ "Литех", Россия, 109651, г. Москва, ул. Перерва, д. 11, стр. 29
- Manufacturing Address
- 119435, Россия, Москва, ул. Малая Пироговская, д. 1, стр. 3
Access comprehensive regulatory information for Reagent kit for detection of DNA of Ureaplasma spp. microorganisms with species differentiation by polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012 For a medical device A set of reagents for the detection of DNA of microorganisms Ureaplasma spp. with differentiation of the species by the polymerase chain reaction method "UREAPOL" according to TU 9398-611-17253567-2012, in the following forms of configuration: 1. Sample preparation kit (DNA isolation), including: - reagent in test tubes for DNA isolation from biosamples for subsequent analysis by polymerase chain reaction (DNA-EXPRESS) - 100 tubes of 300 μl each. 2. Reagent kits for PCR amplification: (a) The Endpoint (CT) format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (100 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (680 μl); - Taq polymerase - 1 tube (30 μl); - diluent - 1 tube (2 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (100 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (100 μl). b) "Real-Time (RT)" format Reagent kit for PCR detection of Ureaplasma urealyticum, Reagent kit for PCR detection of Ureaplasma parvum, Reagent kit for PCR detection of Ureaplasma spp., Each of which includes: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample - 1 tube (200 μl). Fluoroplex reagent kit for PCR detection of Ureaplasma spp. with differentiation of the type, including: - reaction mixture - 1 tube (1360 μl); - Taq polymerase - 1 tube (60 μl); - diluent - 2 tubes (4 ml); - mineral oil - 2 test tubes (4 ml); - positive control DNA sample of Ureaplasma urealyticum - 1 tube (200 μl); - positive control DNA sample of Ureaplasma parvum - 1 tube (200 μl). in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number ФСР 2012/13814 and manufactured by LLC NPF "Litekh". The device was registered on December 25, 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.