Device Dossier

Clinical chemistry vitamin and mineral IVDs

Device Dossier for Clinical chemistry vitamin and mineral IVDs (CT847 - Clinical chemistry vitamin and mineral IVDs, Class 2, sponsor Abacus dx). ARTG…

Intended purpose

VALIDATE Vitamin and/or Mineral kits (such as for Vitamin D) are designed to assist in the documentation of linearity, calibration verification, and verification of linear range or provide assistance when troubleshooting instrument systems, reagent problems, and calibration anomalies.

TGA Public Summary