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Reagent kit for determining the concentration of low-density lipoprotein cholesterol in serum and plasma (LDL-OLVEX CHOLESTEROL) according to TU 9398-054-44276594-2010 Composed of: - precipitating reagent - 1 vial (100 ml) or 3 vials (100 ml each); - calibrator - 1 vial (5.0 ml). - Roszdravnadzor Registration ФСР 2011/11304

Access comprehensive regulatory information for Reagent kit for determining the concentration of low-density lipoprotein cholesterol in serum and plasma (LDL-OLVEX CHOLESTEROL) according to TU 9398-054-44276594-2010 Composed of: - precipitating reagent - 1 vial (100 ml) or 3 vials (100 ml each); - calibrator - 1 vial (5.0 ml). in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2011/11304 and manufactured by OLVEX DIAGNOSTICS LLC. The device was registered on December 27, 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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ФСР 2011/11304
Reagent kit for determining the concentration of low-density lipoprotein cholesterol in serum and plasma (LDL-OLVEX CHOLESTEROL) according to TU 9398-054-44276594-2010 Composed of: - precipitating reagent - 1 vial (100 ml) or 3 vials (100 ml each); - calibrator - 1 vial (5.0 ml).
Набор реагентов для определения концентрации холестерина липопротеинов низкой плотности в сыворотке и плазме крови (ХОЛЕСТЕРИН ЛПНП-ОЛЬВЕКС) по ТУ 9398-054-44276594-2010 в составе: - осаждающий реагент - 1 флакона (100 мл) или 3 флакона (по 100 мл); - калибратор - 1 флакон (5,0 мл).
Roszdravnadzor Registration Number: ФСР 2011/11304
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Device Information
Device Name (English)
Reagent kit for determining the concentration of low-density lipoprotein cholesterol in serum and plasma (LDL-OLVEX CHOLESTEROL) according to TU 9398-054-44276594-2010 Composed of: - precipitating reagent - 1 vial (100 ml) or 3 vials (100 ml each); - calibrator - 1 vial (5.0 ml).
Device Name (Russian)
Набор реагентов для определения концентрации холестерина липопротеинов низкой плотности в сыворотке и плазме крови (ХОЛЕСТЕРИН ЛПНП-ОЛЬВЕКС) по ТУ 9398-054-44276594-2010 в составе: - осаждающий реагент - 1 флакона (100 мл) или 3 флакона (по 100 мл); - калибратор - 1 флакон (5,0 мл).
Device Type (English)
N/A
Device Type (Russian)
146120
Risk Class
N/A
OKPD Code
21.20.23.110
Registration Information
Registry Key
68115.0
Registration Number
ФСР 2011/11304
Registration Date
December 27, 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