Reagent kit for the detection of hepatitis B virus (HBV) DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection "AmpliSense® HBV-FL" Forms of configuration: Form 4: "PCR kit" variant FRT: "PCR kit" version FRT - a set of reagents for amplification of a section of hepatitis B virus (HBV) DNA with hybridization-fluorescence detection in "real time" - includes: 1) PCR mixture-1-FL HBV - 4 tubes (0.3 ml); 2) PCR-buffer-B - 4 tubes (0.2 ml); 3) Polymerase (TaqF) - 4 tubes (0.02 ml); 4) KB2 HBV - 4 tubes (0.1 mL); 5) Elution buffer - 2 tubes (1.2 ml); 6) OKO - 4 tubes (1.2 ml); 7) PCO-1-HBV - 4 tubes (0.06 ml); 8) VKO STI-87 - 4 tubes (0.28 ml); The software, including the operator's manual, can be provided on an electronic data carrier or presented on the official website of the manufacturer (authorized person of the manufacturer): - AmpliSens® HBV Soft software version 1 - 1 pc. - Operator's manual - 1 pc. Operational documentation can be made in paper form and presented on the official website of the manufacturer (authorized person of the manufacturer): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-030-01897593-2012. - Roszdravnadzor Registration ФСР 2007/00585

Access comprehensive regulatory information for Reagent kit for the detection of hepatitis B virus (HBV) DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection "AmpliSense® HBV-FL" Forms of configuration: Form 4: "PCR kit" variant FRT: "PCR kit" version FRT - a set of reagents for amplification of a section of hepatitis B virus (HBV) DNA with hybridization-fluorescence detection in "real time" - includes: 1) PCR mixture-1-FL HBV - 4 tubes (0.3 ml); 2) PCR-buffer-B - 4 tubes (0.2 ml); 3) Polymerase (TaqF) - 4 tubes (0.02 ml); 4) KB2 HBV - 4 tubes (0.1 mL); 5) Elution buffer - 2 tubes (1.2 ml); 6) OKO - 4 tubes (1.2 ml); 7) PCO-1-HBV - 4 tubes (0.06 ml); 8) VKO STI-87 - 4 tubes (0.28 ml); The software, including the operator's manual, can be provided on an electronic data carrier or presented on the official website of the manufacturer (authorized person of the manufacturer): - AmpliSens® HBV Soft software version 1 - 1 pc. - Operator's manual - 1 pc. Operational documentation can be made in paper form and presented on the official website of the manufacturer (authorized person of the manufacturer): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-030-01897593-2012. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2007/00585 and manufactured by Central Research Institute of Epidemiology of Rospotrebnadzor. The device was registered on June 06, 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.