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ADVIA Centaur® Systems HBeAg QC

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® Systems HBeAg QC FDA UDI
Generic Name
Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
Hepatitis B e Antigen (HBeAg) Quality Control Material Kit FDA UDI
Model / Reference
10338289 FDA UDI
Description
Hepatitis B e Antigen (HBeAg) Quality Control Material Kit FDA UDI

Identifiers

Catalog Number
6981117 FDA UDI
Primary DI / UDI-DI
00630414531298 FDA UDI
PMA Number
P090024 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control 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 e-antigen immunoglobulin G (IgG) antibody IVD, control

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

Similar devices

Also classified as Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control.

Cleared under the same submission

P090024 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 269ac110-7507-4af3-aa09-3b4144733212 37 fields · synced May 30, 2026