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).
Russia·133630·HEMA LLC·Registered August 16, 2023·Class 2b- 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
- Registry Key
- 69061.0
- Registration Number
- РЗН 2023/20829
- Registration Date
- August 16, 2023
- 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
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.