ADVIA Centaur® Systems QC SYPH

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur® Systems QC SYPH FDA UDI
Generic Name: Treponema pallidum total antibody IVD, control FDA UDI
Device Name: Syphillis - CENTAUR - CONS - 2x2x7mL FDA UDI
Model / Reference: 10492616 FDA UDI
Description: Syphillis - CENTAUR - CONS - 2x2x7mL FDA UDI

Identifiers

Catalog Number: 10492616 FDA UDI
Primary DI / UDI-DI: 00630414580616 FDA UDI
510(k) Number: K112343 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Treponema pallidum total antibody IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Treponema pallidum total antibody IVD, control

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

Similar devices

Also classified as Treponema pallidum total antibody IVD, control.

Alinity — Abbott · Class I
Syphilis Control — Fujirebio Diagnostics, Inc. · Class I
PreciControl Release Syphilis — Roche Diagnostics Corp. · Class I
Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
LIAISON® Treponema Serum Controls — Diasorin Inc.
MAS Syphilis Positive Control — Microgenics Corporation · Class I
VIROTROL — Bio-Rad Laboratories · Class I
ARCHITECT — Abbott · Class II

Cleared under the same submission

K112343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 64159731-1f3f-4816-a8da-1df2afd013e8 37 fields · synced May 30, 2026