Reagent kit for the determination of AZF locus deletions by real-time PCR (Genetics of hereditary diseases, AZF locus deletions) according to TU 9398-071-46482062-2013 In various configurations: 1. Amplification mixture sealed with paraffin: - standard configuration (for 24 definitions) - 24 strips (8 tubes each); - reduced configuration (packaging for one item for 48 definitions) - 48 tubes or 6 strips of 8 tubes each. 2. Amplification mixture Stream: - packaging for automatic digging stations, incl. for batch studies - 2 strips (8 tubes each). 2.1. PCR Buffer Stream: - packaging for automatic digging stations, incl. for batch studies - 1 tube. 3. Taq-AT polymerase or Taq polymerase solution: - standard configuration (for 24 determinations) - 4 test tubes; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. 4. Mineral Oil: - standard configuration (for 24 determinations) - 4 test tubes; - Reduced configuration (packaging for one item for 48 definitions) - 1 test tube. 5. DNA Dilution Buffer: - packaging for automatic digging stations, incl. for batch studies - 3 test tubes. 6. Positive control sample: - standard configuration (for 24 determinations) - 1 tube; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. 7. Negative Control Sample (Upon Request): - standard configuration (for 24 determinations) - 1 tube; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. II. Accessories: - Tubes with a capacity of 200 μl, stripped, 8 pcs.; - lids for stripped test tubes. - Roszdravnadzor Registration РЗН 2014/2078

Access comprehensive regulatory information for Reagent kit for the determination of AZF locus deletions by real-time PCR (Genetics of hereditary diseases, AZF locus deletions) according to TU 9398-071-46482062-2013 In various configurations: 1. Amplification mixture sealed with paraffin: - standard configuration (for 24 definitions) - 24 strips (8 tubes each); - reduced configuration (packaging for one item for 48 definitions) - 48 tubes or 6 strips of 8 tubes each. 2. Amplification mixture Stream: - packaging for automatic digging stations, incl. for batch studies - 2 strips (8 tubes each). 2.1. PCR Buffer Stream: - packaging for automatic digging stations, incl. for batch studies - 1 tube. 3. Taq-AT polymerase or Taq polymerase solution: - standard configuration (for 24 determinations) - 4 test tubes; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. 4. Mineral Oil: - standard configuration (for 24 determinations) - 4 test tubes; - Reduced configuration (packaging for one item for 48 definitions) - 1 test tube. 5. DNA Dilution Buffer: - packaging for automatic digging stations, incl. for batch studies - 3 test tubes. 6. Positive control sample: - standard configuration (for 24 determinations) - 1 tube; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. 7. Negative Control Sample (Upon Request): - standard configuration (for 24 determinations) - 1 tube; - reduced configuration (packaging for one item for 48 definitions) - 1 test tube; - packaging for automatic digging stations, incl. for batch studies - 1 tube. II. Accessories: - Tubes with a capacity of 200 μl, stripped, 8 pcs.; - lids for stripped test tubes. 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 2014/2078 and manufactured by DNA-Technology TS LLC. The device was registered on August 07, 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.