Reagent kit for the detection of Gardnerella vaginalis DNA by polymerase chain reaction method with "real-time" detection "AmpliPrime® G. vaginalis" according to TU 21.20.23-210-09286667-2023 Dosage forms: I. Dosage form 1 consisting of: 1. PCR mixture of G. vaginalis - 1.20 ml x 1 tube. 2. PCR-buffer-H - 0.65 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. II. Dosage form 2 consisting of: 1. PCR mixture of G. vaginalis - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. Set set: 1. Reagent kit (release form 1 or 2). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. Quality Certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru
Russia·199260·LLC "NextBio"·Registered March 04, 2024·Class 2b- Device Name (English)
- Reagent kit for the detection of Gardnerella vaginalis DNA by polymerase chain reaction method with "real-time" detection "AmpliPrime® G. vaginalis" according to TU 21.20.23-210-09286667-2023 Dosage forms: I. Dosage form 1 consisting of: 1. PCR mixture of G. vaginalis - 1.20 ml x 1 tube. 2. PCR-buffer-H - 0.65 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. II. Dosage form 2 consisting of: 1. PCR mixture of G. vaginalis - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. Set set: 1. Reagent kit (release form 1 or 2). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. Quality Certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru
- Device Name (Russian)
- Набор реагентов для выявления ДНК Gardnerella vaginalis методом полимеразной цепной реакции с детекцией в режиме "реального времени" "АмплиПрайм® G. vaginalis" по ТУ 21.20.23-210-09286667-2023 формы выпуска: I. Форма выпуска 1 в составе: 1. ПЦР-смесь G. vaginalis- 1,20 мл х 1 пробирка. 2. ПЦР-буфер-Н - 0,65 мл х 1 пробирка. 3. ПКО G. vaginalis - 0,26 мл х 1 пробирка. 4. ОКО - 1,10 мл х 1 пробирка. 5. К- - 0,26 мл х 1 пробирка. II. Форма выпуска 2 в составе: 1. ПЦР-смесь G. vaginalis - 0,01 мл х 100 пробирок (12,5 стрипов по 8 пробирок). 2. ПЦР-буфер-К - 1,20 мл х 1 пробирка. 3. ПКО G. vaginalis - 0,26 мл х 1 пробирка. 4. ОКО - 1,10 мл х 1 пробирка. 5. К- - 0,26 мл х 1 пробирка. Комплектность набора: 1. Набор реагентов (форма выпуска 1 или 2). 2. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru 3. Краткое руководство по применению набора в бумажном виде. 4. Комплект вкладышей к набору в бумажном виде. 5. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru
- Device Type (English)
- N/A
- Device Type (Russian)
- 199260
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 75427.0
- Registration Number
- РЗН 2024/22163
- Registration Date
- March 04, 2024
- Manufacturer Name (English)
- LLC "NextBio"
- Manufacturer Name (Russian)
- ООО "НекстБио"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NextBio LLC, Russia, 111394, Moscow, Polimernaya str., 8, bldg. 2
- Legal Address (Russian)
- ООО "НекстБио", Россия, 111394, г. Москва, ул. Полимерная, д. 8, стр. 2
- Manufacturing Address
- 111394, Россия, Москва, ул. Полимерная, д. 8, стр. 2
Access comprehensive regulatory information for Reagent kit for the detection of Gardnerella vaginalis DNA by polymerase chain reaction method with "real-time" detection "AmpliPrime® G. vaginalis" according to TU 21.20.23-210-09286667-2023 Dosage forms: I. Dosage form 1 consisting of: 1. PCR mixture of G. vaginalis - 1.20 ml x 1 tube. 2. PCR-buffer-H - 0.65 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. II. Dosage form 2 consisting of: 1. PCR mixture of G. vaginalis - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. PCO G. vaginalis - 0.26 ml x 1 tube. 4. OKO - 1.10 ml x 1 test tube. 5. K- - 0.26 ml x 1 tube. Set set: 1. Reagent kit (release form 1 or 2). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. Quality Certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru 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 2024/22163 and manufactured by LLC "NextBio". The device was registered on March 04, 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.