FDA.reportPublic FDA data

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)

Primary DI
00845533001960
Brand
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
Company
ZEUS SCIENTIFIC, INC.
Model
FA9601-1010
Catalog number
FA9601-1010
Device description
The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine®. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFine® must be confirmed by a trained operator.
Published
2025-05-12
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)
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533001960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001960008455330019608455330019600845533001960

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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Primary DI, Brand, Company table
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