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 21 083 0144
Certificate history
IVDD 21 083 0144 (Initial issue | 24.May.2022)
Manufacturer/Holder of certificate
Atila Biosystems
740 Sierra Vista Ave, Unit E, Mountain View, CA 94043, USA
Other sites
740 Sierra Vista Ave, Suite F, H
Mountain View, CA 94043 USA
Effective from
24.May.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
iAMP® CT/NG/TV/MG Detection Kit
iAMP CT/NG/TV/MG Detection Kit is a real-time isothermal PCR test for the qualitative detection and differentiation of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) in clinician-collected or self-collected vaginal swab samples, female or male first-void urine samples (defined as the first 20-30 mL of the urine stream), clinician-collected endocervical swabs from females or clinician-collected urethral swabs from males.
Types/Categories/Models:
iAMP-4STI-100-CE (100 tests)
Classification
Device in List B