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Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref A060PL

by Zeus Scientific, Inc.

Identity

Trade Name
Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed) EUDAMED
Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) FDA UDI
Generic Name
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed) EUDAMED
Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-ANCA and P-ANCA. The P-ANCA pattern shows an uneven granular, staining of the cytoplasm. During the 2nd International ANCA Workshop it was agreed that these two different patterns should be used to subclassify the antibodies. Anti-neutrophil cytoplasmic antibody (ANCA)antibody detection by IFA methods has been a useful aid in the assessment of patient diagnosis, and to a certain extent their prognosis and response to therapy. Although there has been much work done with the IFA ANCA, the availability of an MPO-specific enzyme immunoassay (EIA) test has further enhanced the overall picture. The use of EIA and IFA together allows for the best possible patient assessment. The MPO and PR3 EIA allows for a very quick qualitative as well as quantitative report. FDA UDI
Model / Reference
A060PL EUDAMEDFDA UDI
Description
Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-ANCA and P-ANCA. The P-ANCA pattern shows an uneven granular, staining of the cytoplasm. During the 2nd International ANCA Workshop it was agreed that these two different patterns should be used to subclassify the antibodies. Anti-neutrophil cytoplasmic antibody (ANCA)antibody detection by IFA methods has been a useful aid in the assessment of patient diagnosis, and to a certain extent their prognosis and response to therapy. Although there has been much work done with the IFA ANCA, the availability of an MPO-specific enzyme immunoassay (EIA) test has further enhanced the overall picture. The use of EIA and IFA together allows for the best possible patient assessment. The MPO and PR3 EIA allows for a very quick qualitative as well as quantitative report. FDA UDI

Identifiers

Catalog Number
A060PL FDA UDI
Primary DI / UDI-DI
D-A060PLX4 EUDAMED
00845533001991 FDA UDI
Basic UDI-DI
B-A060PLX4 EUDAMED
510(k) Number
K962360 FDA UDI
FDA Product Code
MOB FDA UDI
EMDN Code
W0102100401 ANCA SCREENING EUDAMED
GMDN Term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) by Zeus Scientific, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K962360 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (2)

  • FDA UDI 58bc979a-ab3e-4165-a78c-951a08095e65 36 fields · synced Jun 18, 2026
  • EUDAMED 2f9522fe-991b-4b97-b820-e5dbb8f3d749 61 fields · synced Jun 18, 2026