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pma Primary ID: P210019

ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC) (UDI P210019)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC) - Primary ID P210019

Device Regulatory Overview

The ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC) (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
Verify if facility inventory is affected by this recall.
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ID: Z-1980-2026 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

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 10:06:22

Full Regulatory Attributes

🔒 Token Gated 
{
    "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-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC)?

The registered manufacturer of record for ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC) is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur HBcT2 Quality Control (HBcT2 QC)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P210019.

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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