Microbiological analyzer "BactoSCREEN" according to TU 9443-001-17253567-2015 Composed of: 1. MALDI mass spectrometer LaserToF LT2 Plus - 1 pc. 2. Steel target for 96 positions for applying samples - 5 pcs. 3. Removable handles for carrying the device - 4 pcs. 4. CD (or USB flash drive) with BactoSCREEN-ID microorganism identification software - 1 pc. 5. CD (or USB flash drive) with the database of microorganisms BactoSCREEN-DB - 1 pc. 6. CD (or USB flash drive) with antibiotic susceptibility testing software BactoSCREEN-AST - 1 pc. 7. CD (or USB flash drive) with BactoSCREEN-STAT statistical analysis software - 1 pc. 8. Keyboard Genius KB-110 - 1 pc. 9. 1 x Genius DX-100 Mouse 10. Reagent kit for preparation of bioassay samples for the purpose of subsequent analysis by mass spectrometry (MALDI-TOF-Proba) according to TU 9398-163-172535567-2011 manufactured by LLC NPF LITECH, RUNo FSR 2012/13237 - 1 pc. 11. Operating manual in Russian - 1 pc.
Russia·см. приложение·LLC NPF "Litekh"·Registered December 27, 2023·Class 2a- Device Name (English)
- Microbiological analyzer "BactoSCREEN" according to TU 9443-001-17253567-2015 Composed of: 1. MALDI mass spectrometer LaserToF LT2 Plus - 1 pc. 2. Steel target for 96 positions for applying samples - 5 pcs. 3. Removable handles for carrying the device - 4 pcs. 4. CD (or USB flash drive) with BactoSCREEN-ID microorganism identification software - 1 pc. 5. CD (or USB flash drive) with the database of microorganisms BactoSCREEN-DB - 1 pc. 6. CD (or USB flash drive) with antibiotic susceptibility testing software BactoSCREEN-AST - 1 pc. 7. CD (or USB flash drive) with BactoSCREEN-STAT statistical analysis software - 1 pc. 8. Keyboard Genius KB-110 - 1 pc. 9. 1 x Genius DX-100 Mouse 10. Reagent kit for preparation of bioassay samples for the purpose of subsequent analysis by mass spectrometry (MALDI-TOF-Proba) according to TU 9398-163-172535567-2011 manufactured by LLC NPF LITECH, RUNo FSR 2012/13237 - 1 pc. 11. Operating manual in Russian - 1 pc.
- Device Name (Russian)
- Анализатор микробиологический «BactoSCREEN» по ТУ 9443-001-17253567-2015 в составе: 1. MALDI масс-спектрометр LaserToF LT2 Plus - 1 шт. 2. Стальная мишень на 96 позиций для нанесения образцов - 5 шт. 3. Съемные рукоятки для переноски прибора - 4 шт. 4. Компакт-диск (или USB-флеш диск) с программным обеспечением для идентификации микроорганизмов BactoSCREEN-ID - 1 шт. 5. Компакт-диск (или USB-флеш диск) с базой данных микроорганизмов BactoSCREEN-DB - 1 шт. 6. Компакт-диск (или USB-флеш диск) с программным обеспечением для определения чувствительности к антибиотикам BactoSCREEN-AST - 1 шт. 7. Компакт-диск (или USB-флеш диск) с программным обеспечением для статистического анализа BactoSCREEN-STAT - 1 шт. 8. Клавиатура Genius KB-110 - 1 шт. 9. Мышь Genius DX-100 - 1 шт. 10. Набор реагентов для подготовки образцов биопроб с целью последующего анализа методом масс-спектрометрии (MALDI-TOF-Проба) по ТУ 9398-163-172535567-2011 производства ООО НПФ «ЛИТЕХ», РУ № ФСР 2012/13237 - 1 шт. 11. Руководство по эксплуатации на русском языке - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- см. приложение
- Risk Class
- Class 2a
- OKPD Code
- 26.60.12.119
- Registry Key
- 75989.0
- Registration Number
- РЗН 2016/5127
- Registration Date
- December 27, 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 Microbiological analyzer "BactoSCREEN" according to TU 9443-001-17253567-2015 Composed of: 1. MALDI mass spectrometer LaserToF LT2 Plus - 1 pc. 2. Steel target for 96 positions for applying samples - 5 pcs. 3. Removable handles for carrying the device - 4 pcs. 4. CD (or USB flash drive) with BactoSCREEN-ID microorganism identification software - 1 pc. 5. CD (or USB flash drive) with the database of microorganisms BactoSCREEN-DB - 1 pc. 6. CD (or USB flash drive) with antibiotic susceptibility testing software BactoSCREEN-AST - 1 pc. 7. CD (or USB flash drive) with BactoSCREEN-STAT statistical analysis software - 1 pc. 8. Keyboard Genius KB-110 - 1 pc. 9. 1 x Genius DX-100 Mouse 10. Reagent kit for preparation of bioassay samples for the purpose of subsequent analysis by mass spectrometry (MALDI-TOF-Proba) according to TU 9398-163-172535567-2011 manufactured by LLC NPF LITECH, RUNo FSR 2012/13237 - 1 pc. 11. Operating manual in Russian - 1 pc. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2016/5127 and manufactured by LLC NPF "Litekh". The device was registered on December 27, 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.