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ADVIA Centaur® HBsII

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® HBsII FDA UDI
Generic Name
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
HBsAgII (HBsII) Assay Kit (1-pack) 200T FDA UDI
Model / Reference
10492138 FDA UDI
Description
HBsAgII (HBsII) Assay Kit (1-pack) 200T FDA UDI

Identifiers

Catalog Number
10492138 FDA UDI
Primary DI / UDI-DI
00630414578170 FDA UDI
PMA Number
P110041 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3172 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBsII by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

P110041 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 7859981c-b100-4e0a-ba90-44061450e80d 37 fields · synced Jun 8, 2026