Atila_IVDD 21 084 0145

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 21 084 0145

Certificate history

IVDD 21 084 0145 (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Withdrawn on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 Detection Kit


iAMP CT Detection Kit is an in vitro isothermal PCR assay based on Atila’s proprietary isothermal amplification technology intended for the qualitative detection of Chlamydia trachomatis (CT) 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) without any preservatives, clinician-collected endocervical swabs from females or clinician-collected urethral swabs from males, or clinician-collected ocular swabs


iAMP-CT-100-CE (100 tests)


Device in List B