Reagent for serological identification of Escherichia coli in the agglutination reaction "Escherichia serum OK dry-RA" according to TU 21.20.23-009-96299156-2022 Composed of: I. Escherichiosis serum OK dry-RA, 1 ampoule, execution options: 1. Escherichius serum OK dry-RA O1:K1 (cat. No E. coli - RA-28) 1.0 ml. 2. Escherichius serum OK dry-RA O2:K2 (cat. No E. coli - RA-29) 1.0 ml. 3. Escherichiosis serum OK dry-RA O6:K15 (cat. No E. coli - RA-30) 1.0 ml. 4. Escherichiosis serum OK dry-RA O18:K77 (cat. No E. coli - RA-31) 1.0 ml. 5. Escherichiosis serum OK dry-RA O20:K84 (cat. No E. coli - RA-32) 1.0 ml. 6. Escherichius serum OK dry-RA O25:K11 (cat. No E. coli - RA-33) 1.0 ml. 7. Escherichius serum OK dry-RA O26:K60 (cat. No E. coli - RA-34) 1.0 ml. 8. Escherichius serum OK dry-RA O28:K73 (cat. No E. coli - RA-35) 1.0 ml. 9. Escherichiosis serum OK dry-RA O29:K- (cat, No E. coli - RA-36) 1.0 ml. 10. Escherichiosis serum OK dry-RA O32:K- (cat. No E, coli - RA-37) 1.0 ml. 11. Escherichius serum OK dry-RA O33:K- (cat. No E. coli - RA-38) 1.0 ml. 12. Escherichiosis serum OK dry-RA O44:K74 (cat, No E. coli - RA-39) 1.0 ml. 13. Escherichiosis serum OK dry-RA O55:K59 (cat. No E, coli - RA-40) 1.0 ml. 14. Escherichius serum OK dry-RA O75:K95 (cat. No E. coli - RA-41) 1.0 ml. 15. Escherichiosis serum OK dry-RA O85:K- (cat. No E. coli - RA-42) 1.0 ml. 16. Escherichiosis serum OK dry-RA O86:K61 (cat. No E. coli - RA-43) 1.0 ml. 17. Escherichius serum OK dry-RA O111:K58 (cat. No E. coli - RA-44) 1.0 ml. 18. Escherichius serum OK dry-RA O114:K90 (cat. No E. coli - RA-45) 1.0 ml. 19. Escherichiosis serum OK dry-RA O115:K- (cat. No E. coli - RA-46) 1.0 ml. 20. Escherichius serum OK dry-RA O119:K69 (cat. No E. coli - RA-47) 1.0 ml. 21. Escherichius serum OK dry-RA O124:K72 (cat. No E. coli - RA-48) 1.0 ml. 22. Escherichiosis serum OK dry-RA O125:K70 (cat. No E. coli - RA-49) 1.0 ml. 23. Escherichiosis serum OK dry-RA O126:K71 (cat. No E. coli - RA-50) 1.0 ml. 24. Escherichius serum OK dry-RA O127:K63 (cat. N9 E. coii - RA-51) 1.0 ml. 25. Escherichiosis serum OK dry-RA O128:K67 (cat. No E. coli - RA-52) 1.0 ml. 26. Escherichius serum OK dry-RA O136:K78 (cat. No E. coli - RA-53) 1.0 ml. 27. Escherichiosis serum OK dry-RA O142:K86 (cat, No E. coli - RA-54) 1.0 ml. 28. Escherichius serum OK dry-RA O143:K- (cat. No E. coli - RA-55) 1.0 ml. 29. Escherichius serum OK dry-RA O144:K- (cat. No E. coli - RA-56) 1.0 ml. 30. Escherichius serum OK dry-RA O152:K- (cat. No E. coli - RA-57) 1.0 ml. 31. Escherichius serum OK dry-RA O159:K- (cat. No E. coli - RA-58) 1.0 ml. 32. Escherichius serum OK dry-RA O164:K- (cat. No E. coli - RA-59) 1.0 ml. 33. Escherichiosis serum OK dry-RA "408" (cat. No E.coli - RA-60) 1.0 ml. II. Instructions for use. III. Quality passport. - Roszdravnadzor Registration РЗН 2023/19587

Access comprehensive regulatory information for Reagent for serological identification of Escherichia coli in the agglutination reaction "Escherichia serum OK dry-RA" according to TU 21.20.23-009-96299156-2022 Composed of: I. Escherichiosis serum OK dry-RA, 1 ampoule, execution options: 1. Escherichius serum OK dry-RA O1:K1 (cat. No E. coli - RA-28) 1.0 ml. 2. Escherichius serum OK dry-RA O2:K2 (cat. No E. coli - RA-29) 1.0 ml. 3. Escherichiosis serum OK dry-RA O6:K15 (cat. No E. coli - RA-30) 1.0 ml. 4. Escherichiosis serum OK dry-RA O18:K77 (cat. No E. coli - RA-31) 1.0 ml. 5. Escherichiosis serum OK dry-RA O20:K84 (cat. No E. coli - RA-32) 1.0 ml. 6. Escherichius serum OK dry-RA O25:K11 (cat. No E. coli - RA-33) 1.0 ml. 7. Escherichius serum OK dry-RA O26:K60 (cat. No E. coli - RA-34) 1.0 ml. 8. Escherichius serum OK dry-RA O28:K73 (cat. No E. coli - RA-35) 1.0 ml. 9. Escherichiosis serum OK dry-RA O29:K- (cat, No E. coli - RA-36) 1.0 ml. 10. Escherichiosis serum OK dry-RA O32:K- (cat. No E, coli - RA-37) 1.0 ml. 11. Escherichius serum OK dry-RA O33:K- (cat. No E. coli - RA-38) 1.0 ml. 12. Escherichiosis serum OK dry-RA O44:K74 (cat, No E. coli - RA-39) 1.0 ml. 13. Escherichiosis serum OK dry-RA O55:K59 (cat. No E, coli - RA-40) 1.0 ml. 14. Escherichius serum OK dry-RA O75:K95 (cat. No E. coli - RA-41) 1.0 ml. 15. Escherichiosis serum OK dry-RA O85:K- (cat. No E. coli - RA-42) 1.0 ml. 16. Escherichiosis serum OK dry-RA O86:K61 (cat. No E. coli - RA-43) 1.0 ml. 17. Escherichius serum OK dry-RA O111:K58 (cat. No E. coli - RA-44) 1.0 ml. 18. Escherichius serum OK dry-RA O114:K90 (cat. No E. coli - RA-45) 1.0 ml. 19. Escherichiosis serum OK dry-RA O115:K- (cat. No E. coli - RA-46) 1.0 ml. 20. Escherichius serum OK dry-RA O119:K69 (cat. No E. coli - RA-47) 1.0 ml. 21. Escherichius serum OK dry-RA O124:K72 (cat. No E. coli - RA-48) 1.0 ml. 22. Escherichiosis serum OK dry-RA O125:K70 (cat. No E. coli - RA-49) 1.0 ml. 23. Escherichiosis serum OK dry-RA O126:K71 (cat. No E. coli - RA-50) 1.0 ml. 24. Escherichius serum OK dry-RA O127:K63 (cat. N9 E. coii - RA-51) 1.0 ml. 25. Escherichiosis serum OK dry-RA O128:K67 (cat. No E. coli - RA-52) 1.0 ml. 26. Escherichius serum OK dry-RA O136:K78 (cat. No E. coli - RA-53) 1.0 ml. 27. Escherichiosis serum OK dry-RA O142:K86 (cat, No E. coli - RA-54) 1.0 ml. 28. Escherichius serum OK dry-RA O143:K- (cat. No E. coli - RA-55) 1.0 ml. 29. Escherichius serum OK dry-RA O144:K- (cat. No E. coli - RA-56) 1.0 ml. 30. Escherichius serum OK dry-RA O152:K- (cat. No E. coli - RA-57) 1.0 ml. 31. Escherichius serum OK dry-RA O159:K- (cat. No E. coli - RA-58) 1.0 ml. 32. Escherichius serum OK dry-RA O164:K- (cat. No E. coli - RA-59) 1.0 ml. 33. Escherichiosis serum OK dry-RA "408" (cat. No E.coli - RA-60) 1.0 ml. II. Instructions for use. III. Quality passport. 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 2023/19587 and manufactured by OOO "BioHold". The device was registered on June 03, 2024.

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 2023/19587

Reagent for serological identification of Escherichia coli in the agglutination reaction "Escherichia serum OK dry-RA" according to TU 21.20.23-009-96299156-2022 Composed of: I. Escherichiosis serum OK dry-RA, 1 ampoule, execution options: 1. Escherichius serum OK dry-RA O1:K1 (cat. No E. coli - RA-28) 1.0 ml. 2. Escherichius serum OK dry-RA O2:K2 (cat. No E. coli - RA-29) 1.0 ml. 3. Escherichiosis serum OK dry-RA O6:K15 (cat. No E. coli - RA-30) 1.0 ml. 4. Escherichiosis serum OK dry-RA O18:K77 (cat. No E. coli - RA-31) 1.0 ml. 5. Escherichiosis serum OK dry-RA O20:K84 (cat. No E. coli - RA-32) 1.0 ml. 6. Escherichius serum OK dry-RA O25:K11 (cat. No E. coli - RA-33) 1.0 ml. 7. Escherichius serum OK dry-RA O26:K60 (cat. No E. coli - RA-34) 1.0 ml. 8. Escherichius serum OK dry-RA O28:K73 (cat. No E. coli - RA-35) 1.0 ml. 9. Escherichiosis serum OK dry-RA O29:K- (cat, No E. coli - RA-36) 1.0 ml. 10. Escherichiosis serum OK dry-RA O32:K- (cat. No E, coli - RA-37) 1.0 ml. 11. Escherichius serum OK dry-RA O33:K- (cat. No E. coli - RA-38) 1.0 ml. 12. Escherichiosis serum OK dry-RA O44:K74 (cat, No E. coli - RA-39) 1.0 ml. 13. Escherichiosis serum OK dry-RA O55:K59 (cat. No E, coli - RA-40) 1.0 ml. 14. Escherichius serum OK dry-RA O75:K95 (cat. No E. coli - RA-41) 1.0 ml. 15. Escherichiosis serum OK dry-RA O85:K- (cat. No E. coli - RA-42) 1.0 ml. 16. Escherichiosis serum OK dry-RA O86:K61 (cat. No E. coli - RA-43) 1.0 ml. 17. Escherichius serum OK dry-RA O111:K58 (cat. No E. coli - RA-44) 1.0 ml. 18. Escherichius serum OK dry-RA O114:K90 (cat. No E. coli - RA-45) 1.0 ml. 19. Escherichiosis serum OK dry-RA O115:K- (cat. No E. coli - RA-46) 1.0 ml. 20. Escherichius serum OK dry-RA O119:K69 (cat. No E. coli - RA-47) 1.0 ml. 21. Escherichius serum OK dry-RA O124:K72 (cat. No E. coli - RA-48) 1.0 ml. 22. Escherichiosis serum OK dry-RA O125:K70 (cat. No E. coli - RA-49) 1.0 ml. 23. Escherichiosis serum OK dry-RA O126:K71 (cat. No E. coli - RA-50) 1.0 ml. 24. Escherichius serum OK dry-RA O127:K63 (cat. N9 E. coii - RA-51) 1.0 ml. 25. Escherichiosis serum OK dry-RA O128:K67 (cat. No E. coli - RA-52) 1.0 ml. 26. Escherichius serum OK dry-RA O136:K78 (cat. No E. coli - RA-53) 1.0 ml. 27. Escherichiosis serum OK dry-RA O142:K86 (cat, No E. coli - RA-54) 1.0 ml. 28. Escherichius serum OK dry-RA O143:K- (cat. No E. coli - RA-55) 1.0 ml. 29. Escherichius serum OK dry-RA O144:K- (cat. No E. coli - RA-56) 1.0 ml. 30. Escherichius serum OK dry-RA O152:K- (cat. No E. coli - RA-57) 1.0 ml. 31. Escherichius serum OK dry-RA O159:K- (cat. No E. coli - RA-58) 1.0 ml. 32. Escherichius serum OK dry-RA O164:K- (cat. No E. coli - RA-59) 1.0 ml. 33. Escherichiosis serum OK dry-RA "408" (cat. No E.coli - RA-60) 1.0 ml. II. Instructions for use. III. Quality passport.

Реагент для серологической идентификации Escherichia coli в реакции агглютинации "Сыворотка эшерихиозная ОК сухая-РА" по ТУ 21.20.23-009-96299156-2022 в составе: I. Сыворотка эшерихиозная ОК сухая-РА, 1 ампула, варианты исполнения: 1. Сыворотка эшерихиозная ОК сухая-РА О1:К1 (кат. № Е. coli - РА - 28) 1,0 мл. 2. Сыворотка эшерихиозная ОК сухая-РА О2:К2 (кат. № Е. coli - РА - 29) 1,0 мл. 3. Сыворотка эшерихиозная ОК сухая-РА О6:К15 (кат. № Е. coli - РА - 30) 1,0 мл. 4. Сыворотка эшерихиозная ОК сухая-РА О18:К77 (кат. № Е. coli - РА - 31) 1,0 мл. 5. Сыворотка эшерихиозная ОК сухая-РА О20:К84 (кат. № Е. coli - РА - 32) 1,0 мл. 6. Сыворотка эшерихиозная ОК сухая-РА О25:К11 (кат. № Е. coli - РА - 33) 1,0 мл. 7. Сыворотка эшерихиозная ОК сухая-РА О26:К60 (кат. № Е. coli - РА - 34) 1,0 мл. 8. Сыворотка эшерихиозная ОК сухая-РА О28:К73 (кат. № Е. coli - РА - 35) 1,0 мл. 9. Сыворотка эшерихиозная ОК сухая-РА О29:К- (кат, № Е. coli - РА - 36) 1,0 мл. 10. Сыворотка эшерихиозная ОК сухая-РА О32:К- (кат. № Е, coli - РА - 37) 1,0 мл. 11. Сыворотка эшерихиозная ОК сухая-РА О33:К- (кат. № Е. coli - РА - 38) 1,0 мл. 12. Сыворотка эшерихиозная ОК сухая-РА О44:К74 (кат, № Е. coli - РА - 39) 1,0 мл. 13. Сыворотка эшерихиозная ОК сухая-РА О55:К59 (кат. № Е, coli - РА - 40) 1,0 мл. 14. Сыворотка эшерихиозная ОК сухая-РА О75:К95 (кат. № Е. coli - РА - 41) 1,0 мл. 15. Сыворотка эшерихиозная ОК сухая-РА О85:К- (кат. № Е. coli - РА - 42) 1,0 мл. 16. Сыворотка эшерихиозная ОК сухая-РА О86:К61 (кат. № Е. coli - РА - 43) 1,0 мл. 17. Сыворотка эшерихиозная ОК сухая-РА О111:К58 (кат. № Е. coli - РА - 44) 1,0 мл. 18. Сыворотка эшерихиозная ОК сухая-РА О114:К90 (кат. № Е. coli - РА - 45) 1,0 мл. 19. Сыворотка эшерихиозная ОК сухая-РА О115:К- (кат. № Е. coli - РА - 46) 1,0 мл. 20. Сыворотка эшерихиозная ОК сухая-РА О119:К69 (кат. № Е. coli - РА - 47) 1.0 мл. 21. Сыворотка эшерихиозная ОК сухая-РА О124:К72 (кат. № Е. coli - РА - 48) 1,0 мл. 22. Сыворотка эшерихиозная ОК сухая-РА О125:К70 (кат. № Е. coli - РА - 49) 1,0 мл. 23. Сыворотка эшерихиозная ОК сухая-РА О126:К71 (кат. № Е. coli - РА - 50) 1,0 мл. 24. Сыворотка эшерихиозная ОК сухая-РА О127:К63 (кат. N9 Е. coii - РА - 51) 1,0 мл. 25. Сыворотка эшерихиозная ОК сухая-РА О128:К67 (кат. № Е. coli - РА - 52) 1,0 мл. 26. Сыворотка эшерихиозная ОК сухая-РА О136:К78 (кат. № Е. coli - РА - 53) 1,0 мл. 27. Сыворотка эшерихиозная ОК сухая-РА О142:К86 (кат, № Е. coli - РА - 54) 1,0 мл. 28. Сыворотка эшерихиозная ОК сухая-РА О143:К- (кат. № Е. coli - РА - 55) 1,0 мл. 29. Сыворотка эшерихиозная ОК сухая-РА О144:К- (кат. № Е. coli - РА - 56) 1,0 мл. 30. Сыворотка эшерихиозная ОК сухая-РА О152:К- (кат. № Е. coli - РА - 57) 1,0 мл. 31. Сыворотка эшерихиозная ОК сухая-РА О159:К- (кат. № Е. coli - РА - 58) 1,0 мл. 32. Сыворотка эшерихиозная ОК сухая-РА О164:К- (кат. № Е. coli - РА - 59) 1,0 мл. 33. Сыворотка эшерихиозная ОК сухая-РА «408» (кат. № Е.coli - РА - 60) 1,0 мл. II. Инструкция по применению. III. Паспорт качества.

Roszdravnadzor Registration Number: РЗН 2023/19587

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Device Information

Device Name (English)

Device Name (Russian)

Device Type (English)

N/A

Device Type (Russian)

160810

Risk Class

Class 2b

OKPD Code

21.20.23.110

Registration Information

Registry Key

79382.0

Registration Number

РЗН 2023/19587

Registration Date

June 03, 2024

Manufacturer Information

Manufacturer Name (English)

OOO "BioHold"

Manufacturer Name (Russian)

ООО "БиоХолд"

Country (English)

Russia

Country (Russian)

Россия

Legal Address (English)

NPP DiaVita LLC, Pionerskaya st., 4, room 203, Korolev, Moscow region, 141074 Russia

Legal Address (Russian)

ООО "НПП "ДиаВита", Россия, 141074, Московская область, г. Королев, ул. Пионерская, д. 4, к. 203

Manufacturing Address

111394, Россия, Москва, вн.тер.г. муниципальный округ Новогиреево, ул. Перовская, д. 61/2, стр. 1