Atila_IVDD 21 083 0144

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


Valid until


Suspension period
Withdrawn on
Validity status
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.


iAMP-4STI-100-CE (100 tests)


Device in List B