AmpliPrime® B. burgdorferi sensu lato DNA reagent kit for the detection of Borrelia burgdorferi sensu lato by polymerase chain reaction with real-time detection according to TU 21.20.23-223-09286667-2023 In versions: I. Dosage form 1, consisting of: 1. PCR mixture Bbsl - 1.20 ml x 1 tube. 2. PCR-buffer-H - 0.65 ml x 1 tube. 3. PCO Bbsl - 0.26 ml x 1 tube. 4. VKO-FL - 1.10 ml x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. II. Dosage form 2, consisting of: 1. PCR mixture Bbsl - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. PCO Bbsl - 0.26 ml x 1 tube. 4. VKO-FL - 1.10 ml x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. - Roszdravnadzor Registration РЗН 2024/23181
Access comprehensive regulatory information for AmpliPrime® B. burgdorferi sensu lato DNA reagent kit for the detection of Borrelia burgdorferi sensu lato by polymerase chain reaction with real-time detection according to TU 21.20.23-223-09286667-2023 In versions: I. Dosage form 1, consisting of: 1. PCR mixture Bbsl - 1.20 ml x 1 tube. 2. PCR-buffer-H - 0.65 ml x 1 tube. 3. PCO Bbsl - 0.26 ml x 1 tube. 4. VKO-FL - 1.10 ml x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. II. Dosage form 2, consisting of: 1. PCR mixture Bbsl - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. PCO Bbsl - 0.26 ml x 1 tube. 4. VKO-FL - 1.10 ml x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. 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 2024/23181 and manufactured by LLC "NextBio". The device was registered on July 25, 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.
