Monoclonal dot-immunoenzyme test system for the detection of tularemia microbe (DIATul-M) according to TU 9388-040-01898109-2011 - phosphate-saline buffer (FSB) - 1 white tablet 1.01 g; - skimmed milk powder (lactalbumin) - cream-colored powder, 15 mg; - CATul (tularemia peroxidase immunoglobulin conjugate) is an amorphous brownish mass representing monoclonal immunoglobulins to lipopolysaccharide (LPS) F. tularensis, conjugated with horseradish peroxidase, lyophilized; - Tween-20 - viscous slightly yellowish liquid, 0.0075 ml; - DAB (3,3-diaminobenzidine) - brown powder, 2 mg; - hydroperite (urea, peroxide) - 1 white tablet 1.5 g; - positive control specimen (PCO-TM) - an amorphous mass of yellowish color, which is an inactivated lyophilized suspension of F. tularensis at a concentration of 1×109 m.q./ml; - Nitrocellulose membrane filter (FMNC in a Petri dish) - a white plate of 20×25 mm with 3×3 mm markings, sensitized with monoclonal mouse immunoglobulins to F. tularensis LPS with subsequent blocking with lactalbumin. The FMRC is placed in a single-use laboratory Petri dish with a lid, D 40 mm - Roszdravnadzor Registration ФСР 2012/13944

Access comprehensive regulatory information for Monoclonal dot-immunoenzyme test system for the detection of tularemia microbe (DIATul-M) according to TU 9388-040-01898109-2011 - phosphate-saline buffer (FSB) - 1 white tablet 1.01 g; - skimmed milk powder (lactalbumin) - cream-colored powder, 15 mg; - CATul (tularemia peroxidase immunoglobulin conjugate) is an amorphous brownish mass representing monoclonal immunoglobulins to lipopolysaccharide (LPS) F. tularensis, conjugated with horseradish peroxidase, lyophilized; - Tween-20 - viscous slightly yellowish liquid, 0.0075 ml; - DAB (3,3-diaminobenzidine) - brown powder, 2 mg; - hydroperite (urea, peroxide) - 1 white tablet 1.5 g; - positive control specimen (PCO-TM) - an amorphous mass of yellowish color, which is an inactivated lyophilized suspension of F. tularensis at a concentration of 1×109 m.q./ml; - Nitrocellulose membrane filter (FMNC in a Petri dish) - a white plate of 20×25 mm with 3×3 mm markings, sensitized with monoclonal mouse immunoglobulins to F. tularensis LPS with subsequent blocking with lactalbumin. The FMRC is placed in a single-use laboratory Petri dish with a lid, D 40 mm in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2012/13944 and manufactured by Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor. The device was registered on September 26, 2022.

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.