Certificate verification page
Certification scheme
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system (excl. 4 and 6)
Certificate number
IVDD 21 090 0134
Certificate history
IVDD 21 090 0134 (Initial issue | 23.May.2022)
Manufacturer/Holder of certificate
DNA-Technology Research&Production LLC
Zheleznodorozhnaya street, 20, Moscow region, Protvino, 142281, Russia
Other sites
“DNA-Technology” LLC, Varshavskoye shosse, 125 Zh, building 5, floor 1, office 12, int. ter. Municipal District Chertanovo Severnoye, Moscow, 117587, Russia
“DNA-Technology R&D”, LLC, Gurianova street, 83, bld.1, Moscow, 109388, Russia
“DNA-Technology TS”, LLC, Nauchnyi proyezd, 20, bld.4., 117246, Moscow, Russia
“DNA-Technology, Research&Production”, LLC Zheleznodorozhnaya street 3, Moscow region, Protvino, 142281, Russia
Effective from
23.May.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
Femoflor Screen REAL-TIME PCR Detection Kit
Femoflor Screen REAL-TIME PCR Detection Kit is intended for research and diagnostic applications. The kit is an in vitro Nucleic Acid Test (NAT) – pathogen detection-based product and intended to detect pathogens, opportunistic flora and normal flora in women’s urogenital specimens by multiplex Real-Time PCR method. Samples are human biological materials: epithelial scrapes from cervical canal, posterolateral vaginal vault and urethra.
Femoflor Screen REAL-TIME PCR Detection Kit is simultaneous, comprehensive diagnostics, using one biological sample:
– qualitative detection of pathogens of genitourinary diseases in women (Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma genitalium, Cytomegalovirus, Herpes simplex virus 1, Herpes simplex virus 2, involved in the development of dysbiotic processes in urogenital microbiocenosis);
– microbiota composition assessment: urogenital normoflora – lactobacilli, obligate-anaerobic microorganisms – Gardnerella vaginalis/Prevotella bivia/Porphyromonasspp., typical for the women’s urogenital tract, mycoplasmas – Mycoplasma hominis, Ureaplasmaspp., fungi of the Candida genus.
Types/Categories/Models:
Package S (standard): (R1-P804-S3/5EU) – 24 tests
Package A (automated dosing): (R1-P804-XA/4EU) – 48 tests
Classification
Device in List B