Set of reagents Enzyme-linked immunosorbent assay test system for detecting antibodies to Treponema pallidum (ELISA-antipallidum-screen) according to TU 9398-025-70423725-2011 Set No. 1: - immunosorbent; - control positive sample (K+); - control negative sample (K-); - conjugate; - chromogen (... (see the full description in the card)
Russia·Unknown·CJSC EKOlab·Registered June 21, 2018·Class 2b- Device Name (English)
- Set of reagents Enzyme-linked immunosorbent assay test system for detecting antibodies to Treponema pallidum (ELISA-antipallidum-screen) according to TU 9398-025-70423725-2011 Set No. 1: - immunosorbent; - control positive sample (K+); - control negative sample (K-); - conjugate; - chromogen (... (see the full description in the card)
- Device Name (Russian)
- Набор реагентов Тест -система иммуноферментная для выявления антител к Treponema pallidum (ИФА-антипаллидум-скрин) по ТУ 9398-025-70423725-2011 Комплект №1: - иммуносорбент; - контрольный положительный образец (К+); - контрольный отрицательный образец (К-); - конъюгат; - хромоген (... (см. в карточке полное описание)
- Device Type (English)
- N/A
- Device Type (Russian)
- Unknown
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 30049
- Registration Number
- ФСР 2011/12216
- Registration Date
- June 21, 2018
- Validity Period
- January 01, 2262
- Manufacturer Name (English)
- CJSC EKOlab
- Manufacturer Name (Russian)
- ЗАО ЭКОлаб
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 142530, Moscow, region, Elektrogorsk, Budyonny str., 1
- Legal Address (Russian)
- 142530 Россия Московская область г. Электрогорск ул. Буденного д. 1
- Manufacturing Address
- 1. ЗАО «ЭКОлаб» Россия 142530 Московская обл. г. Электрогорск ул. Буденного д. 1.2. ЗАО «ЭКОлаб» Россия 142530 Московская обл. г. Электрогорск ул. Буденного д. 1а.
Access comprehensive regulatory information for Set of reagents Enzyme-linked immunosorbent assay test system for detecting antibodies to Treponema pallidum (ELISA-antipallidum-screen) according to TU 9398-025-70423725-2011 Set No. 1: - immunosorbent; - control positive sample (K+); - control negative sample (K-); - conjugate; - chromogen (... (see the full description in the card) 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 2011/12216 and manufactured by CJSC EKOlab. The device was registered on June 21, 2018.
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.