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Reagent kit for qualitative and semi-quantitative determination of antistreptolysin O content in blood serum by latex-agglutination (ASO-OLVEX) according to TU 9398-011-44276594-2003 - Roszdravnadzor Registration ФСР 2008/03031

Access comprehensive regulatory information for Reagent kit for qualitative and semi-quantitative determination of antistreptolysin O content in blood serum by latex-agglutination (ASO-OLVEX) according to TU 9398-011-44276594-2003 in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФСР 2008/03031 and manufactured by OLVEX DIAGNOSTICS LLC. The device was registered on December 28, 2022.

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 2a
ФСР 2008/03031
Reagent kit for qualitative and semi-quantitative determination of antistreptolysin O content in blood serum by latex-agglutination (ASO-OLVEX) according to TU 9398-011-44276594-2003
Набор реагентов для качественного и полуколичественного определения содержания антистрептолизина О в сыворотке крови методом латекс-агглютинации (АСО-ОЛЬВЕКС) по ТУ 9398-011-44276594-2003
Roszdravnadzor Registration Number: ФСР 2008/03031
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Device Information
Device Name (English)
Reagent kit for qualitative and semi-quantitative determination of antistreptolysin O content in blood serum by latex-agglutination (ASO-OLVEX) according to TU 9398-011-44276594-2003
Device Name (Russian)
Набор реагентов для качественного и полуколичественного определения содержания антистрептолизина О в сыворотке крови методом латекс-агглютинации (АСО-ОЛЬВЕКС) по ТУ 9398-011-44276594-2003
Device Type (English)
N/A
Device Type (Russian)
331000
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
68112.0
Registration Number
ФСР 2008/03031
Registration Date
December 28, 2022
Manufacturer Information
Manufacturer Name (English)
OLVEX DIAGNOSTICS LLC
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
OLVEX DIAGNOSTICUM LLC, 10 Oktyabrskaya nab., bldg. 1, bldg. 1, St. Petersburg, 193091 Russia
Legal Address (Russian)
ООО "ОЛЬВЕКС ДИАГНОСТИКУМ", Россия, 193091, Санкт-Петербург, Октябрьская наб., д. 10, к. 1, стр. 1
Manufacturing Address
199155, Россия, Санкт-Петербург, пер. Декабристов, д. 5/17, кв. 1