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Buffer negative control material in the Buffer Negative Control Kit cassette for quality control and evaluation of the validity of results on the cobas® 6800 system (cobas® Buffer Negative Control Kit) series G09553 - Roszdravnadzor Registration РЗН 2020/11610

Access comprehensive regulatory information for Buffer negative control material in the Buffer Negative Control Kit cassette for quality control and evaluation of the validity of results on the cobas® 6800 system (cobas® Buffer Negative Control Kit) series G09553 in the Russia medical device market through Pure Global AI's free database. This Class 3 medical device is registered under Roszdravnadzor registration number РЗН 2020/11610 and manufactured by Roche Diagnostics GmbH. The device was registered on August 05, 2020.

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 3
РЗН 2020/11610
Buffer negative control material in the Buffer Negative Control Kit cassette for quality control and evaluation of the validity of results on the cobas® 6800 system (cobas® Buffer Negative Control Kit) series G09553
Буферный отрицательный контрольный материал в кассете Buffer Negative Control Kit для контроля качества и оценки валидности результатов на системе автоматизированной cobas® 6800 (cobas® Buffer Negative Control Kit) серия G09553
Roszdravnadzor Registration Number: РЗН 2020/11610
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Device Information
Device Name (English)
Buffer negative control material in the Buffer Negative Control Kit cassette for quality control and evaluation of the validity of results on the cobas® 6800 system (cobas® Buffer Negative Control Kit) series G09553
Device Name (Russian)
Буферный отрицательный контрольный материал в кассете Buffer Negative Control Kit для контроля качества и оценки валидности результатов на системе автоматизированной cobas® 6800 (cobas® Buffer Negative Control Kit) серия G09553
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 3
OKPD Code
21.20.23.110
Registration Information
Registry Key
45729
Registration Number
РЗН 2020/11610
Registration Date
August 05, 2020
Validity Period
January 01, 2021
Manufacturer Information
Manufacturer Name (English)
Roche Diagnostics GmbH
Manufacturer Name (Russian)
Рош Диагностикс ГмбХ
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
68305 Германия Дальнее зарубежье Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Legal Address (Russian)
68305 Германия Дальнее зарубежье Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Manufacturing Address
Roche Molecular Systems Inc. 1080 US Highway 202 Branchburg New Jersey 08876 USA