IDS-iSYS Ostase® BAP

Model / Reference

IS-2800

Primary DI / UDI-DI

05060169690202

Basic UDI-DI

B-05060169690202

EMDN Code

W0102060399 Bone metabolism tests - other

Device Class

Class IVD General

Market of Registration

Belgium

EUDAMED SRN

GB-MF-000015851

Authorised representative

Immunodiagnostic Systems SA BE-AR-000015342

• IDS Cortisol

  Class II

  FDA 510(k) K202136 Active Cleared 13 Apr 2021

• Ids Shbg

  Class I

  FDA 510(k) K190121 Active Cleared 17 Jun 2019

• IDS SS-A/Ro

  Class II

  FDA 510(k) K253817 Active Cleared 21 Aug 2026

• IDS High Sensitive Estradiol Calibrator Set

  Class B

  CE/IVDR GUDID on market

• IDS-iSYS Direct Renin Control Set

  IVD General

  CE/IVDD

• IDS High Sensitive Estradiol Control Set

  Class B

  CE/IVDR GUDID on market

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