DNA_IVDD 21 089 0133

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 21 089 0133

Certificate history

IVDD 21 089 0133 (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

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Products within scope

Androflor REAL-TIME PCR Detection Kit
Androflor Screen REAL-TIME PCR Detection Kit


Androflor and Androflor Screen REAL-TIME PCR Detection Kits are intended for research and diagnostic applications. The kits are an in vitro Nucleic Acid Test (NAT) –pathogen-detection-based products designed to detect the total bacterial DNA (total bacterial mass), DNA of the opportunistic and true pathogens in men’s urogenital tract by multiplex Real-Time Polymerase Chain Reaction (PCR) method. The kits are simultaneous, comprehensive diagnostics:

  • qualitative detection  of  pathogens  of  genitourinary  diseases  in  men  (Neisseria  gonorrhoeae Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium);
  • microbiota composition assessment (a wide range of microorganisms that may be present in the genitourinary tract  in  men  as  normobiota,  as  well  as  be  the  cause  of  infectious  and  inflammatory diseases of the genitourinary system: Staphylococcus spp., Streptococcus spp., Corynebacterium spp., Lactobacillus spp., Gardnerella vaginalis, Atopobium cluster (Atopobium spp., Olsenella spp., Collinsella spp.), Megasphaera spp. / Veilonella spp. / Dialister spp., Sneathia spp. / Leptotrihia spp. /Fuso-bacterium spp., Ureaplasma urealyticum, Ureaplasma    parvum, Mycoplasma hominis, Bacteroides spp./ Porphyromonas spp./ Prevotella spp., Anaerococcus spp., Peptostreptococcus spp. / Parvimonas spp., Eubacterium spp., Pseudomonas  aeruginosa / Ralstonia spp. /Burkholderia spp., Enterobacteriaceae family/ Enterococcus spp., Heamophilus spp., as well as fungi of the genus Candida spp.).

Samples are human biological materials: epithelial scrapes from the balanus and urethra, urina, prostate fluid, ejaculate, biopsy samples from prostatic tissues.


Package S: (R1-P809-S3/6EU, R1-P810 -S3/5EU) 12 tests / 24 tests
Package A: (R1-P809-XA/5EU, R1-P810 -XA/4EU) 24 tests / 48 tests


Device in List B