Reagent kit for the qualitative determination of the 27 locus B allele of the main human histocompatibility complex by real-time PCR AmpliSense® HLA-B27-FL, TU 21.20.23-373-01897593-2024 , forms of configuration: I. Form 1: "PCR kit" version FRT-50 F, consisting of: 1. Part 1 of 2. Composition: 1.1. K+ DNA - 1 0.2 ml X 1 pc. 1.2. K - - 0.2 ml X 1 pc. 1.3. OKO - 1.2 ml X 1 pc. 1.4 Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc. 2. Part 2 of 2. Composition: 2.1. PCR-mixture-FL HLA-B27 - 0.6 ml x 1 pc. 2.2. PCR-buffer-C - 0.3 ml X 1 pc. 2.3. Polymerase (TaqF) - 0.03 ml x 1 pc. II. Form 2: "PCR kit" version FRT-L, consisting of: 1. PCR mixture HLA-B27-Lyo - 48 pcs. 2. K+ DNA 1 - 0.2ml X 1pc 3. K- - 0.5 ml X 1 pc. 4. OKO 1.2ml X 1pc 5. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc.
Russia·315760·Central Research Institute of Epidemiology of Rospotrebnadzor·Registered September 23, 2024·Class 2b- Device Name (English)
- Reagent kit for the qualitative determination of the 27 locus B allele of the main human histocompatibility complex by real-time PCR AmpliSense® HLA-B27-FL, TU 21.20.23-373-01897593-2024 , forms of configuration: I. Form 1: "PCR kit" version FRT-50 F, consisting of: 1. Part 1 of 2. Composition: 1.1. K+ DNA - 1 0.2 ml X 1 pc. 1.2. K - - 0.2 ml X 1 pc. 1.3. OKO - 1.2 ml X 1 pc. 1.4 Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc. 2. Part 2 of 2. Composition: 2.1. PCR-mixture-FL HLA-B27 - 0.6 ml x 1 pc. 2.2. PCR-buffer-C - 0.3 ml X 1 pc. 2.3. Polymerase (TaqF) - 0.03 ml x 1 pc. II. Form 2: "PCR kit" version FRT-L, consisting of: 1. PCR mixture HLA-B27-Lyo - 48 pcs. 2. K+ DNA 1 - 0.2ml X 1pc 3. K- - 0.5 ml X 1 pc. 4. OKO 1.2ml X 1pc 5. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc.
- Device Name (Russian)
- Набор реагентов для качественного определения аллеля 27 локуса В главного комплекса гистосовместимости человека методом ПЦР в режиме реального времени АмплиСенс® HLA-B27-FL, ТУ 21.20.23-373-01897593-2024 , формы комплектации: I. Форма 1: «ПЦР-комплект» вариант FRT-50 F, в составе: 1. Часть 1 из 2. Состав: 1.1. К+ ДНК - 1 0,2 мл X 1 шт. 1.2. К - - 0,2 мл X 1 шт. 1.3. ОКО - 1,2 мл X 1 шт. 1.4 Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - 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. Часть 2 из 2. Состав: 2.1. ПЦР-смесь-FL HLA-B27 - 0,6 мл х 1 шт. 2.2. ПЦР-буфер-С - 0,3 мл X 1 шт. 2.3. Полимераза (TaqF) - 0,03 мл х 1 шт. II. Форма 2: «ПЦР-комплект» вариант FRT-L, в составе: 1. ПЦР-смесь HLA-B27-Lyo - 48 шт. 2. К+ ДНК 1 - 0,2 мл X 1 шт. 3. К- - 0,5 мл X 1 шт. 4. ОКО 1,2 мл X 1 шт. 5. Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - инструкция по применению - 1 шт.; - паспорт качества набора реагентов - 1 шт.; - вкладыш к набору реагентов - 1 комплект; - краткое руководство к набору реагентов - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 315760
- Risk Class
- Class 2b
- OKPD Code
- 20.59.52.195
- Registry Key
- 81887
- Registration Number
- РЗН 2024/23700
- Registration Date
- September 23, 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 Reagent kit for the qualitative determination of the 27 locus B allele of the main human histocompatibility complex by real-time PCR AmpliSense® HLA-B27-FL, TU 21.20.23-373-01897593-2024 , forms of configuration: I. Form 1: "PCR kit" version FRT-50 F, consisting of: 1. Part 1 of 2. Composition: 1.1. K+ DNA - 1 0.2 ml X 1 pc. 1.2. K - - 0.2 ml X 1 pc. 1.3. OKO - 1.2 ml X 1 pc. 1.4 Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc. 2. Part 2 of 2. Composition: 2.1. PCR-mixture-FL HLA-B27 - 0.6 ml x 1 pc. 2.2. PCR-buffer-C - 0.3 ml X 1 pc. 2.3. Polymerase (TaqF) - 0.03 ml x 1 pc. II. Form 2: "PCR kit" version FRT-L, consisting of: 1. PCR mixture HLA-B27-Lyo - 48 pcs. 2. K+ DNA 1 - 0.2ml X 1pc 3. K- - 0.5 ml X 1 pc. 4. OKO 1.2ml X 1pc 5. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick guide to the reagent kit - 1 pc. 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 2024/23700 and manufactured by Central Research Institute of Epidemiology of Rospotrebnadzor. The device was registered on September 23, 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.