ELISA-Toxo-IgM reagent kit enzyme immunoassay system for the detection of class M antibodies to Toxoplasma gondii according to TU 9398-077-70423725-2010 Composed of: - Immunosorbent. - Control positive sample (K+). - A positive control sample of the "slice" level (K+por). - Control negative sample (K-). - Conjugate (x51). - Conjugate dilution solution (PPB). - 25-fold concentrate of phosphate-saline buffer solution with twin [(FSB-T(x25)]. - Sample dilution solution (PPO). - Indicator solution (RI). - Stop reagent.
Russia·255190·ECOlab JSC·Registered September 25, 2024·Class 2b- Device Name (English)
- ELISA-Toxo-IgM reagent kit enzyme immunoassay system for the detection of class M antibodies to Toxoplasma gondii according to TU 9398-077-70423725-2010 Composed of: - Immunosorbent. - Control positive sample (K+). - A positive control sample of the "slice" level (K+por). - Control negative sample (K-). - Conjugate (x51). - Conjugate dilution solution (PPB). - 25-fold concentrate of phosphate-saline buffer solution with twin [(FSB-T(x25)]. - Sample dilution solution (PPO). - Indicator solution (RI). - Stop reagent.
- Device Name (Russian)
- Набор реагентов "ИФА-Токсо-IgМ" тест-система иммуноферментная для выявления антител класса М к Toxoplasma gondii по ТУ 9398-077-70423725-2010 в составе: - Иммуносорбент. - Контрольный положительный образец (К+). - Контрольный положительный образец уровня "среза" (К+пор). - Контрольный отрицательный образец (К-). - Конъюгат (х51). - Раствор для разведения конъюгата (РРК). - 25-кратный концентрат фосфатно-солевого буферного раствора с твином [(ФСБ-Т(х25)]. - Раствор для разведения образцов (РРО). - Раствор индикаторный (РИ). - Стоп-реагент.
- Device Type (English)
- N/A
- Device Type (Russian)
- 255190
- Risk Class
- Class 2b
- OKPD Code
- 20.59.52.195
- Registry Key
- 81928
- Registration Number
- ФСР 2011/12068
- Registration Date
- September 25, 2024
- Manufacturer Name (English)
- ECOlab JSC
- Manufacturer Name (Russian)
- АО "ЭКОлаб"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- ECOlab JSC, 1a, Budennogo Street, Elektrogorsk, Pavlovo-Posadsky, Moscow Region, 142530, Russia
- Legal Address (Russian)
- АО "ЭКОлаб", Россия, 142530, Московская область, г.о. Павлово - Посадский, г. Электрогорск, ул. Буденного, д. 1а
- Manufacturing Address
- 142530, Россия, Московская область, г.о. Павлово-Посадский, г. Электрогорск, ул. Буденного, д. 1
Access comprehensive regulatory information for ELISA-Toxo-IgM reagent kit enzyme immunoassay system for the detection of class M antibodies to Toxoplasma gondii according to TU 9398-077-70423725-2010 Composed of: - Immunosorbent. - Control positive sample (K+). - A positive control sample of the "slice" level (K+por). - Control negative sample (K-). - Conjugate (x51). - Conjugate dilution solution (PPB). - 25-fold concentrate of phosphate-saline buffer solution with twin [(FSB-T(x25)]. - Sample dilution solution (PPO). - Indicator solution (RI). - Stop reagent. 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 2011/12068 and manufactured by ECOlab JSC. The device was registered on September 25, 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.