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 21 019 0118
Certificate history
IVDD 21 019 0118 (Initial issue | 28.Mar.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
28.Mar.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
CMV REAL-TIME PCR Detection Kit
The CMV REAL-TIME PCR Detection Kit is an in vitro Nucleic Acid Test (NAT) for qualitative pathogen detection. The CMV REAL-TIME PCR Detection Kit is designed to detect CMV nucleic acids in human biological samples with an aid of Polymerase Chain Reaction (PCR) method. Samples are human biological materials: saliva, urine, prostate fluid, ejaculate, swabs from urethra and conjunctiva of the eye, cervix, or posterolateral vaginal wall, breast milk, peripheral blood mononuclear cells, liquor, amniotic fluid, tissue samples.
Types/Categories/Models:
Package S: R1-P204-23/9EU and R1-P204-S3/9EU (96 tubes, 12 8-tube strips)
Package U: R1-P204-UA/9EU (96 reactions)
Classification
Device in List B