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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. - Roszdravnadzor Registration ФСР 2011/12068

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.

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Class 2b
ФСР 2011/12068
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.
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.
Roszdravnadzor Registration Number: ФСР 2011/12068
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Device Information
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
Registration Information
Registry Key
81928
Registration Number
ФСР 2011/12068
Registration Date
September 25, 2024
Manufacturer Information
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