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A set of reagents for the enzyme-linked immunosorbent determination of free prostate-specific antigen in blood serum (OncoELISA-free PSA). - Roszdravnadzor Registration ФС 012а2003/5438-06

Access comprehensive regulatory information for A set of reagents for the enzyme-linked immunosorbent determination of free prostate-specific antigen in blood serum (OncoELISA-free PSA). in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФС 012а2003/5438-06 and manufactured by Alkor Bio Company Ltd.. The device was registered on December 29, 2006.

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
ФС 012а2003/5438-06
A set of reagents for the enzyme-linked immunosorbent determination of free prostate-specific antigen in blood serum (OncoELISA-free PSA).
Набор реагентов для иммуноферментного определения свободного простат-специфического антигена в сыворотке крови (ОнкоИФА-свободный ПСА).
Roszdravnadzor Registration Number: ФС 012а2003/5438-06
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Device Information
Device Name (English)
A set of reagents for the enzyme-linked immunosorbent determination of free prostate-specific antigen in blood serum (OncoELISA-free PSA).
Device Name (Russian)
Набор реагентов для иммуноферментного определения свободного простат-специфического антигена в сыворотке крови (ОнкоИФА-свободный ПСА).
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 2a
OKPD Code
93 9817
Registration Information
Registry Key
o25532
Registration Number
ФС 012а2003/5438-06
Registration Date
December 29, 2006
Validity Period
December 29, 2011
Manufacturer Information
Manufacturer Name (English)
Alkor Bio Company Ltd.
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
190000St. Petersburg, Dekabristov str., 6, pom. 10-H
Legal Address (Russian)
190000Санкт-Петербург ул.Декабристов д.6 пом. 10-Н