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 21 020 0115
Certificate history
IVDD 21 020 0115 (Initial issue | 09.Feb.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
09.Feb.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
Chlamydia trachomatis REAL-TIME PCR Detection Kit
The Chlamydia trachomatis REAL-TIME PCR Detection Kit offers an in vitro nucleic acid based test for qualitative pathogen detection. The test uses the Polymerase Chain Reaction (PCR) nucleic acid amplification technique aimed to detect Chlamydia trachomatis in urogenital specimens
Types/Categories/Models:
R1-P101-S3/9EU, R1-P101-23/9EU, R1-P101-UA/9EU
96 tubes, 12 8-tube strips
Classification
Device in List B
