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ADVIA Centaur® aCCP IgG

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® aCCP IgG FDA UDI
Generic Name
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
CCP IgG Ab - CENTAUR - RGT - 100 tests FDA UDI
Model / Reference
10699141 FDA UDI
Description
CCP IgG Ab - CENTAUR - RGT - 100 tests FDA UDI

Identifiers

Catalog Number
10699141 FDA UDI
Primary DI / UDI-DI
00630414592312 FDA UDI
510(k) Number
K153551 FDA UDI
FDA Product Code
NHX FDA UDI
GMDN Term
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K153551 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 ae551a64-938d-45c1-a161-517eb74035c6 36 fields · synced May 30, 2026