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ADVIA Centaur® HBcT

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® HBcT FDA UDI
Generic Name
Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
HBc Total (HBcT) Assay Kit 200T FDA UDI
Model / Reference
10309508 FDA UDI
Description
HBc Total (HBcT) Assay Kit 200T FDA UDI

Identifiers

Catalog Number
7566733 FDA UDI
Primary DI / UDI-DI
00630414498096 FDA UDI
PMA Number
P040004 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus core total antibody 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 core total antibody IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

P040004 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 5ade200e-6169-40b7-b63d-5067dc336f74 37 fields · synced May 30, 2026