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Reagent kit for immunochromatographic detection of mycobacterial lipoarabinomannic antigen in biological fluids "XEMATect LAMAg" as per TU 21.20.23-013-18619450-2022 Composed of: 1. Cassette - 6 pcs. 2. Sample processing buffer - 1 pc. (3.0 ml). 3. Sample neutralization buffer - 1 pc. (0.5 ml). 4. Instructions for use - 1 pc. 5. Passport (one for a transport container or group package). - Roszdravnadzor Registration РЗН 2023/20829

Access comprehensive regulatory information for Reagent kit for immunochromatographic detection of mycobacterial lipoarabinomannic antigen in biological fluids "XEMATect LAMAg" as per TU 21.20.23-013-18619450-2022 Composed of: 1. Cassette - 6 pcs. 2. Sample processing buffer - 1 pc. (3.0 ml). 3. Sample neutralization buffer - 1 pc. (0.5 ml). 4. Instructions for use - 1 pc. 5. Passport (one for a transport container or group package). in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2023/20829 and manufactured by HEMA LLC. The device was registered on August 16, 2023.

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
РЗН 2023/20829
Reagent kit for immunochromatographic detection of mycobacterial lipoarabinomannic antigen in biological fluids "XEMATect LAMAg" as per TU 21.20.23-013-18619450-2022 Composed of: 1. Cassette - 6 pcs. 2. Sample processing buffer - 1 pc. (3.0 ml). 3. Sample neutralization buffer - 1 pc. (0.5 ml). 4. Instructions for use - 1 pc. 5. Passport (one for a transport container or group package).
Набор реагентов для иммунохроматографического выявления липоарабиноманнового антигена микобактерий в биологических жидкостях "XEMATecт LAMAg" по ТУ 21.20.23-013-18619450-2022 в составе: 1. Кассета - 6 шт. 2. Буфер для обработки образца - 1 шт. (3,0 мл). 3. Буфер для нейтрализации образца - 1 шт. (0,5 мл). 4. Инструкция по применению - 1 шт. 5. Паспорт (один на транспортную тару или групповую упаковку).
Roszdravnadzor Registration Number: РЗН 2023/20829
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Device Information
Device Name (English)
Reagent kit for immunochromatographic detection of mycobacterial lipoarabinomannic antigen in biological fluids "XEMATect LAMAg" as per TU 21.20.23-013-18619450-2022 Composed of: 1. Cassette - 6 pcs. 2. Sample processing buffer - 1 pc. (3.0 ml). 3. Sample neutralization buffer - 1 pc. (0.5 ml). 4. Instructions for use - 1 pc. 5. Passport (one for a transport container or group package).
Device Name (Russian)
Набор реагентов для иммунохроматографического выявления липоарабиноманнового антигена микобактерий в биологических жидкостях "XEMATecт LAMAg" по ТУ 21.20.23-013-18619450-2022 в составе: 1. Кассета - 6 шт. 2. Буфер для обработки образца - 1 шт. (3,0 мл). 3. Буфер для нейтрализации образца - 1 шт. (0,5 мл). 4. Инструкция по применению - 1 шт. 5. Паспорт (один на транспортную тару или групповую упаковку).
Device Type (English)
N/A
Device Type (Russian)
133630
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
69061.0
Registration Number
РЗН 2023/20829
Registration Date
August 16, 2023
Manufacturer Information
Manufacturer Name (English)
HEMA LLC
Manufacturer Name (Russian)
ООО "ХЕМА"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
LLC "KEMA", Russia, 143900, Moscow region, Balashikha, Trubetskaya str., vld. 2B
Legal Address (Russian)
ООО "ХЕМА", Россия, 143900, Московская область, г. Балашиха, ул. Трубецкая, влд. 2В
Manufacturing Address
125319, Россия, Москва, ул. 4-я Восьмого марта, д. 3, стр. 3, помещ. 2