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ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Qua…

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K153551Ref 10699140Model IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM

by Axis-Shield Diagnostics Limited

Identity

Trade Name
ADVIA Centaur anti-CCP IgG (aCCP) Master Curve Material (MCM) EUDAMED
ADVIA Centaur® aCCP IgG MCM FDA UDI
Generic Name
Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI
Device Name
IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM EUDAMED
Anti-CCP IgG (aCCP) MCM FDA UDI
Model / Reference
10699140 EUDAMEDFDA UDI
IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM EUDAMED
Description
Anti-CCP IgG (aCCP) MCM FDA UDI

Identifiers

Catalog Number
10699140 FDA UDI
Primary DI / UDI-DI
00630414592305 EUDAMEDFDA UDI
Basic UDI-DI
0405686900756VZ EUDAMED
510(k) Number
K153551 FDA 510(k)FDA UDI
FDA Product Code
NHX FDA 510(k)
JJX FDA UDI
EMDN Code
W0102152010 CONTROLS FOR RHEUMATOLOGY EUDAMED
GMDN Term
Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA 510(k)
Class I FDA UDI
Legislation / Framework
21 CFR Part 866.5775 FDA 510(k)
Regulation Number
866.5775 FDA 510(k)
862.1660 FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Qua… by Axis-Shield Diagnostics Limited — Class II — IVDR, FDA_510K — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Axis-Shield Diagnostics Limited

Sources (3)

  • FDA 510(k) K153551 24 fields · synced Aug 1, 2026
  • FDA UDI 979a520e-213b-4870-9d2e-83ae146aaece 36 fields · synced May 25, 2026
  • EUDAMED 67684c29-2928-4950-b502-76041957ce58 61 fields · synced Aug 1, 2026