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In vitro reagents for the bacteriological analyzer Bactec MGIT 960 (see Appendix on sheet 1)I. Nutrient media 1. Middlebrook Liquid Culture Media with Fluorescent Component in Test Tubes [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Middlebrook ADC Enrichment 3. The basis of Middlebrook broth in modification 7H9 [Middlebrook 7H9 Broth Base] 4. Enrichment additive [BBL TM MGIT TM OADC] 5. BBL TM Lowenstein-Jensen medium slaints 6. Lowenstein-Jensen with Glycerol and PACT 7. Middlebrook and Koch 7H11 agar slaints 8. Middlebrook OADC enrichment 9. Middlebrook broth in modification 7H9 [Middlebrook 7H9 broth] 10. Antibiotic Susceptibility Medium Additive [BBL TM MGIT TM AST SIRE Kit] II. Reagents for staining and sample preparation 1. Fluorescent dye for staining smears [TB fluorescent Strain Kit] 2. Dye for quick staining of smears [TB quick strain Kit] 3. Acridine orange dye for staining smears [Acridine orange strain] 4. Fluorescent dye for staining smears T [TB fluorescent Strain Kit T] 5. Dye for coloring smears according to Quinoin [TB strain Kit K] 6. Dye for coloring smears according to Ziel-Nielsen [TB ZN strain Kit] 7. Decolorizing solution [TB decolorizer] 8. Sputum decontamination reagent [BBL TM MGIT TM PANTA TM] 9. Sputum Sample Preparation and Decontamination Reagent [BBL TM Mycoprep Kit] - Roszdravnadzor Registration ФС № 2004/482

Access comprehensive regulatory information for In vitro reagents for the bacteriological analyzer Bactec MGIT 960 (see Appendix on sheet 1)I. Nutrient media 1. Middlebrook Liquid Culture Media with Fluorescent Component in Test Tubes [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Middlebrook ADC Enrichment 3. The basis of Middlebrook broth in modification 7H9 [Middlebrook 7H9 Broth Base] 4. Enrichment additive [BBL TM MGIT TM OADC] 5. BBL TM Lowenstein-Jensen medium slaints 6. Lowenstein-Jensen with Glycerol and PACT 7. Middlebrook and Koch 7H11 agar slaints 8. Middlebrook OADC enrichment 9. Middlebrook broth in modification 7H9 [Middlebrook 7H9 broth] 10. Antibiotic Susceptibility Medium Additive [BBL TM MGIT TM AST SIRE Kit] II. Reagents for staining and sample preparation 1. Fluorescent dye for staining smears [TB fluorescent Strain Kit] 2. Dye for quick staining of smears [TB quick strain Kit] 3. Acridine orange dye for staining smears [Acridine orange strain] 4. Fluorescent dye for staining smears T [TB fluorescent Strain Kit T] 5. Dye for coloring smears according to Quinoin [TB strain Kit K] 6. Dye for coloring smears according to Ziel-Nielsen [TB ZN strain Kit] 7. Decolorizing solution [TB decolorizer] 8. Sputum decontamination reagent [BBL TM MGIT TM PANTA TM] 9. Sputum Sample Preparation and Decontamination Reagent [BBL TM Mycoprep Kit] in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФС № 2004/482 and manufactured by Becton Dickinson. The device was registered on May 21, 2004.

This page provides complete registration details including device type, manufacturer information, country of origin (USA), 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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ФС № 2004/482
In vitro reagents for the bacteriological analyzer Bactec MGIT 960 (see Appendix on sheet 1)I. Nutrient media 1. Middlebrook Liquid Culture Media with Fluorescent Component in Test Tubes [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Middlebrook ADC Enrichment 3. The basis of Middlebrook broth in modification 7H9 [Middlebrook 7H9 Broth Base] 4. Enrichment additive [BBL TM MGIT TM OADC] 5. BBL TM Lowenstein-Jensen medium slaints 6. Lowenstein-Jensen with Glycerol and PACT 7. Middlebrook and Koch 7H11 agar slaints 8. Middlebrook OADC enrichment 9. Middlebrook broth in modification 7H9 [Middlebrook 7H9 broth] 10. Antibiotic Susceptibility Medium Additive [BBL TM MGIT TM AST SIRE Kit] II. Reagents for staining and sample preparation 1. Fluorescent dye for staining smears [TB fluorescent Strain Kit] 2. Dye for quick staining of smears [TB quick strain Kit] 3. Acridine orange dye for staining smears [Acridine orange strain] 4. Fluorescent dye for staining smears T [TB fluorescent Strain Kit T] 5. Dye for coloring smears according to Quinoin [TB strain Kit K] 6. Dye for coloring smears according to Ziel-Nielsen [TB ZN strain Kit] 7. Decolorizing solution [TB decolorizer] 8. Sputum decontamination reagent [BBL TM MGIT TM PANTA TM] 9. Sputum Sample Preparation and Decontamination Reagent [BBL TM Mycoprep Kit]
Реагенты in vitro для анализатора бактериологического Bactec MGIT 960 (см. Приложение на 1 листе)I. Питательные среды 1. Жидкая питательная среда Миддлбрук с флуоресцентным компонентом в пробирках [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Обогащающая добавка к среде Миддлбрук [Middlebrook ADC Enrichment] 3. Основа бульона Миддлбрук в модификации 7Н9 [Middlebrook 7H9 Broth Base] 4. Обогащающая добавка [BBL TM MGIT TM OADC] 5. Слайды со средой Левенштейн-Йенсен [BBL TM Lowenstein-Jensen medium slaints] 6. Среда Левенштейн-Йенсен ПАКТ [Lowenstein-Jensen with Glycerol and PACT] 7. Среда Миддлбрук и Кох в модификации 7Н11 [Middlebrook and Koch 7H11 agar slaints] 8. Обогащающая добавка ОАДС для среды Миддлбрук [Middlebrook OADC enrichment] 9. Бульон Миддлбрук в модификации 7Н9 [Middlebrook 7H9 broth] 10. Добавка к среде для определения антибиотикочувствительности [BBL TM MGIT TM AST SIRE Kit] II. Реагенты для окраски и пробоподготовки 1. Краситель флюоресцентый для окрашивания мазков [TB fluorescent Strain Kit] 2. Краситель для быстрого окрашивания мазков [TB quick strain Kit] 3. Краситель Акридин оранжевый для окрашивания мазков [Acridine orange strain] 4. Краситель флуоресцентный для окрашивания мазков Т [TB fluorescent Strain Kit T] 5. Краситель для окраски мазков по Киноину [TB strain Kit K] 6. Краситель для окраски мазков по Циль-Нильсену [TB ZN strain Kit ] 7. Обесцвечивающий раствор [TB decolorizer] 8. Реагент для деконтаминации мокроты [BBL TM MGIT TM PANTA TM] 9. Реагент для пробоподготовки и деконтаминации мокроты [BBL TM Mycoprep Kit]
Roszdravnadzor Registration Number: ФС № 2004/482
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Device Information
Device Name (English)
In vitro reagents for the bacteriological analyzer Bactec MGIT 960 (see Appendix on sheet 1)I. Nutrient media 1. Middlebrook Liquid Culture Media with Fluorescent Component in Test Tubes [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Middlebrook ADC Enrichment 3. The basis of Middlebrook broth in modification 7H9 [Middlebrook 7H9 Broth Base] 4. Enrichment additive [BBL TM MGIT TM OADC] 5. BBL TM Lowenstein-Jensen medium slaints 6. Lowenstein-Jensen with Glycerol and PACT 7. Middlebrook and Koch 7H11 agar slaints 8. Middlebrook OADC enrichment 9. Middlebrook broth in modification 7H9 [Middlebrook 7H9 broth] 10. Antibiotic Susceptibility Medium Additive [BBL TM MGIT TM AST SIRE Kit] II. Reagents for staining and sample preparation 1. Fluorescent dye for staining smears [TB fluorescent Strain Kit] 2. Dye for quick staining of smears [TB quick strain Kit] 3. Acridine orange dye for staining smears [Acridine orange strain] 4. Fluorescent dye for staining smears T [TB fluorescent Strain Kit T] 5. Dye for coloring smears according to Quinoin [TB strain Kit K] 6. Dye for coloring smears according to Ziel-Nielsen [TB ZN strain Kit] 7. Decolorizing solution [TB decolorizer] 8. Sputum decontamination reagent [BBL TM MGIT TM PANTA TM] 9. Sputum Sample Preparation and Decontamination Reagent [BBL TM Mycoprep Kit]
Device Name (Russian)
Реагенты in vitro для анализатора бактериологического Bactec MGIT 960 (см. Приложение на 1 листе)I. Питательные среды 1. Жидкая питательная среда Миддлбрук с флуоресцентным компонентом в пробирках [BD BBL TM Prepared Culture Media/ BBLTM MGIT TM Mycobacteria Growth Indicator Tubes] 2. Обогащающая добавка к среде Миддлбрук [Middlebrook ADC Enrichment] 3. Основа бульона Миддлбрук в модификации 7Н9 [Middlebrook 7H9 Broth Base] 4. Обогащающая добавка [BBL TM MGIT TM OADC] 5. Слайды со средой Левенштейн-Йенсен [BBL TM Lowenstein-Jensen medium slaints] 6. Среда Левенштейн-Йенсен ПАКТ [Lowenstein-Jensen with Glycerol and PACT] 7. Среда Миддлбрук и Кох в модификации 7Н11 [Middlebrook and Koch 7H11 agar slaints] 8. Обогащающая добавка ОАДС для среды Миддлбрук [Middlebrook OADC enrichment] 9. Бульон Миддлбрук в модификации 7Н9 [Middlebrook 7H9 broth] 10. Добавка к среде для определения антибиотикочувствительности [BBL TM MGIT TM AST SIRE Kit] II. Реагенты для окраски и пробоподготовки 1. Краситель флюоресцентый для окрашивания мазков [TB fluorescent Strain Kit] 2. Краситель для быстрого окрашивания мазков [TB quick strain Kit] 3. Краситель Акридин оранжевый для окрашивания мазков [Acridine orange strain] 4. Краситель флуоресцентный для окрашивания мазков Т [TB fluorescent Strain Kit T] 5. Краситель для окраски мазков по Киноину [TB strain Kit K] 6. Краситель для окраски мазков по Циль-Нильсену [TB ZN strain Kit ] 7. Обесцвечивающий раствор [TB decolorizer] 8. Реагент для деконтаминации мокроты [BBL TM MGIT TM PANTA TM] 9. Реагент для пробоподготовки и деконтаминации мокроты [BBL TM Mycoprep Kit]
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
N/A
Registration Information
Registry Key
o64711
Registration Number
ФС № 2004/482
Registration Date
May 21, 2004
Validity Period
May 21, 2009
Manufacturer Information
Manufacturer Name (English)
Becton Dickinson
Manufacturer Name (Russian)
Becton Dickinson
Country (English)
USA
Country (Russian)
USA
Legal Address (English)
United States
Legal Address (Russian)
США