FDA.reportPublic FDA data

Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)

Primary DI
00845533001991
Brand
Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)
Company
ZEUS SCIENTIFIC, INC.
Model
A060PL
Catalog number
A060PL
Device 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.
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962360000IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESScimedx Corp.1996-09-30MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533001991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001991008455330019918455330019910845533001991

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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