Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10

Albania medical device registration · Abbott Ireland Diagnostics Division Finisklin Business Park, Sligo, Ireland · Invitro · Model Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10 · Registered February 23, 2022

Device classification

Risk Class: Invitro
Product Model: Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10
Product Name: Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10

Registration information

Registration Date: February 23, 2022
Analysis ID: 11324

Manufacturer

Name: Abbott Ireland Diagnostics Division Finisklin Business Park, Sligo, Ireland

Product information

Imunoanalize, kalibrator dhe kontroll per percaktimin e Hepatiti B

About this record

Access comprehensive regulatory information for Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10 in the Albania medical device market through Pure Global AI's free database. This Invitro medical device is manufactured by Abbott Ireland Diagnostics Division Finisklin Business Park, Sligo, Ireland. The device was registered on February 23, 2022.

This page provides complete registration details including product model (Architect HBaAg Reagent Kit: 6C36-22 (4x100 teste), 6C36-27 (1x100teste), 6C36-29 (1x100 teste), 6C36-32 (4x500 teste), 6C36-34 (4x500 teste), 6C36-35 (1x500teste); Architect HBsAg Calibrators: 3M61-01, 3M61-02; Architect HBsAg Controls: 6C36-10), manufacturer information, risk classification, and regulatory compliance data from the official Albania medical device database. Pure Global AI offers free access to Albania's medical device registry, helping global MedTech companies navigate Albania regulations efficiently.