pma Primary ID: P100039

ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B (UDI P100039)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification LOM within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2703-2026 View Full Alert →

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536....

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-2398-2026 View Full Alert →

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay...

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-1980-2026 View Full Alert →

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079....

🔒 Compromised Lot & Serial Numbers Locked

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Technical Specifications

Model Number: N/A
Product Code / EMDN: LOM
Device Name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Database Sync Date: 2026-08-09 10:04:44

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B?

The registered manufacturer of record for ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P100039.

What classification code is assigned to this device?

This device is registered under product classification code LOM.

Similar Classification Devices (LOM)

Other Devices by Siemens Healthcare Diagnostics, Inc.

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