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
24.May.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
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
Types/Categories/Models:
iAMP-CT-100-CE (100 tests)
Classification
Device in List B
