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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

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.

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Albania Official Data
Invitro
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
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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