Paediatric urine collection/analysis kit IVD

Definition
A collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It can be used at home by a caregiver and at the point-of-care by a healthcare professional. This is a single-use device.
GUDID devices
2
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10704411008040AMSureĀ® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.12018-06-01
10704411008057AMSureĀ® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.12018-06-01