AmpliSense® Mycoplasma genitalium-FL reagent kit for detection of Mycoplasma genitalium DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection Forms of configuration: 1. FEP Format 1.1 Form 1: "PCR kit" version FEP (0.5 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Mineral oil for PCR - 1 vial (4.0 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FEP (0.2 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 2. FRT Format 1.1 Form 1: "PCR kit" version FRT, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 1 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FRT-100 F, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 1 tube (1.2 ml); - PCR mixture-2-FRT - 2 tubes (0.3 ml); - Polymerase (TaqF) - 2 tubes (0.03 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 2 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-042-01897593-2009
Russia·255480·Central Research Institute of Epidemiology of Rospotrebnadzor·Registered June 06, 2024·Class 2b- Device Name (English)
- AmpliSense® Mycoplasma genitalium-FL reagent kit for detection of Mycoplasma genitalium DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection Forms of configuration: 1. FEP Format 1.1 Form 1: "PCR kit" version FEP (0.5 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Mineral oil for PCR - 1 vial (4.0 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FEP (0.2 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 2. FRT Format 1.1 Form 1: "PCR kit" version FRT, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 1 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FRT-100 F, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 1 tube (1.2 ml); - PCR mixture-2-FRT - 2 tubes (0.3 ml); - Polymerase (TaqF) - 2 tubes (0.03 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 2 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-042-01897593-2009
- Device Name (Russian)
- Набор реагентов для выявления ДНК Mycoplasma genitalium в клиническом материале методом полимеразной цепной реакции (ПЦР) с гибридизационно-флуоресцентной детекцией "АмплиСенс® Mycoplasma genitalium-FL" Формы комплектации: 1. Формат FEP 1.1 Форма 1: «ПЦР-комплект» вариант FEP (пробирки 0,5 мл), в составе: - ПЦР-смесь-1-FL Mycoplasma genitalium - 110 пробирок (0,01 мл); - ПЦР-смесь-2-FL-red - 1 пробирка (1,1 мл); - ПЦР-смесь-Фон-red - 1 пробирка (0,6 мл); - Минеральное масло для ПЦР - 1 флакон (4,0 мл); - ПКО комплексный - 1 пробирка (0,2 мл); - ДНК-буфер - 1 пробирка (0,5 мл). - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (уполномоченного представителя): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт. 1.2 Форма 2: «ПЦР-комплект» вариант FEP (пробирки 0,2 мл), в составе: - ПЦР-смесь-1-FL Mycoplasma genitalium - 110 пробирок (0,01 мл); - ПЦР-смесь-2-FL-red - 1 пробирка (1,1 мл); - ПЦР-смесь-Фон-red - 1 пробирка (0,6 мл); - ПКО комплексный - 1 пробирка (0,2 мл); - ДНК-буфер - 1 пробирка (0,5 мл). - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (уполномоченного представителя): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт. 2. Формат FRT 1.1 Форма 1: «ПЦР-комплект» вариант FRT, в составе: - ПЦР-смесь-1-FL Mycoplasma genitalium - 110 пробирок (0,01 мл); - ПЦР-смесь-2-FL-red - 1 пробирка (1,1 мл); - ПКО комплексный - 1 пробирка (0,2 мл); - ДНК-буфер - 1 пробирка (0,5 мл). - Программное обеспечение на электронном носителе или на сайте Изготовителя (уполномоченного представителя): - Программное обеспечение AmpliSens® Mycoplasma genitalium Soft Form 1 версия 1 - 1 шт.; - Руководство оператора - 1 шт. - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (уполномоченного представителя): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт. 1.2 Форма 2: «ПЦР-комплект» вариант FRT-100 F, в составе: - ПЦР-смесь-1-FL Mycoplasma genitalium - 1 пробирка (1,2 мл); - ПЦР-смесь-2-FRT - 2 пробирки (0,3 мл); - Полимераза (TaqF) - 2 пробирки (0,03 мл); - ПКО комплексный - 1 пробирка (0,2 мл); - ДНК-буфер - 1 пробирка (0,5 мл). - Программное обеспечение на электронном носителе или на сайте Изготовителя (уполномоченного представителя): - Программное обеспечение AmpliSens® Mycoplasma genitalium Soft Form 2 версия 1 - 1 шт.; - Руководство оператора - 1 шт. - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (уполномоченного представителя): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт. Техническая документация: ТУ 9398-042-01897593-2009
- Device Type (English)
- N/A
- Device Type (Russian)
- 255480
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 79493.0
- Registration Number
- ФСР 2007/00580
- Registration Date
- June 06, 2024
- Manufacturer Name (English)
- Central Research Institute of Epidemiology of Rospotrebnadzor
- Manufacturer Name (Russian)
- ФБУН ЦНИИ Эпидемиологии Роспотребнадзора
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. Central Research Institute of Epidemiology of Rospotrebnadzor, Russia, 111123, Moscow, Novogireevskaya str., 3A. 2. Central Research Institute of Epidemiology of Rospotrebnadzor, Russia, 111123, Moscow, Novogireevskaya str., 3A, bldg. 6.
- Legal Address (Russian)
- 1. ФБУН ЦНИИ Эпидемиологии Роспотребнадзора, Россия, 111123, Москва, ул Новогиреевская, д. 3А. 2. ФБУН ЦНИИ Эпидемиологии Роспотребнадзора, Россия, 111123, Москва, ул Новогиреевская, д. 3А стр. 6.
- Manufacturing Address
- 111123, Россия, Москва, ул. Новогиреевская, д. 3А
Access comprehensive regulatory information for AmpliSense® Mycoplasma genitalium-FL reagent kit for detection of Mycoplasma genitalium DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection Forms of configuration: 1. FEP Format 1.1 Form 1: "PCR kit" version FEP (0.5 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Mineral oil for PCR - 1 vial (4.0 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FEP (0.2 ml tubes), consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - PCR-mixture-Fon-red - 1 tube (0.6 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 2. FRT Format 1.1 Form 1: "PCR kit" version FRT, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 110 tubes (0.01 ml); - PCR mixture-2-FL-red - 1 tube (1.1 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 1 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. 1.2 Form 2: "PCR kit" version FRT-100 F, consisting of: - PCR mixture-1-FL Mycoplasma genitalium - 1 tube (1.2 ml); - PCR mixture-2-FRT - 2 tubes (0.3 ml); - Polymerase (TaqF) - 2 tubes (0.03 ml); - Complex PCS - 1 tube (0.2 ml); - DNA buffer - 1 tube (0.5 ml). - Software on electronic media or on the website of the Manufacturer (authorized representative): - Software AmpliSens® Mycoplasma genitalium Soft Form 2 version 1 - 1 pc.; - Operator's manual - 1 pc. - Operational documentation on paper and on the website of the Manufacturer (authorized representative): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-042-01897593-2009 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 2007/00580 and manufactured by Central Research Institute of Epidemiology of Rospotrebnadzor. The device was registered on June 06, 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.