Alegria Flash MPO

Primary DI
00845533003513
Brand
Alegria Flash MPO
Company
ZEUS SCIENTIFIC, INC.
Model
CL28131
Catalog number
CL28131
Device description
The Alegria Flash MPO kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to MPO in human serum. It is intended for use as an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
Published
2026-05-15
Public version status
New
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
00845533003513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003513008455330035138455330035130845533003513

GMDN Terms#

Term, Definition table
TermDefinition
Myeloperoxidase (MPO) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of myeloperoxidase (MPO) in a clinical specimen, using a chemiluminescent immunoassay method. MPO is used as a marker of cardiovascular disease (e.g., atherosclerosis, coronary artery disease, heart failure).

Storage And Handling#

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

Regulatory Flags#

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

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