ELISA ANCA Screen Smart Kit Test System

Primary DI
00845533000161
Brand
ELISA ANCA Screen Smart Kit Test System
Company
ZEUS SCIENTIFIC, INC.
Model
SM2Z9681G
Catalog number
SM2Z9681G
Device description
The ZEUS ELISA ANCA Screen Test System is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533000161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533000161008455330001618455330001610845533000161

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3).

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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