FDA.reportPublic FDA data

Alegria Flash PR3

Primary DI
00845533003490
Brand
Alegria Flash PR3
Company
ZEUS SCIENTIFIC, INC.
Model
CL28141
Catalog number
CL28141
Device description
The Alegria Flash PR3 kit uses chemiluminescent immunoassay (CLIA) technology for the quantitative measurement of IgG antibodies to PR3 in human serum. It is intended for use as an aid in the diagnosis of granulomatosis with polyangiitis (GPA) 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
00845533003490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003490008455330034908455330034900845533003490

GMDN Terms#

Term, Definition table
TermDefinition
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase-3 (PR3) in a clinical specimen, using a chemiluminescent immunoassay method.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845533003681Herpes Simplex Virus-1 (HSV-1) IgMFA9051MFA9051M2026-06-09
00845533003698Herpes Simplex Virus-2 (HSV-2) IgGFA9052GFA9052G2026-06-09
00845533003582Alegria Flash SSA-60CL28001CL280012026-06-08
00845533003599Alegria Flash SSA-60 Control KitCL28001CKCL28001CK2026-06-08
00845533003605Alegria Flash SSA-52CL28011CL280112026-06-08
00845533003612Alegria Flash SSA-52 Control KitCL28011CKCL28011CK2026-06-08
00845533003629Alegria Flash SSBCL28021CL280212026-06-08
00845533003636Alegria Flash SSB Control KitCL28021CKCL28021CK2026-06-08
00845533003643Cytomegalovirus (CMV) IgGFA9001GFA9001G2026-06-08
00845533003650Cytomegalovirus (CMV) IgMmFA9001MFA9001M2026-06-08
00845533003667Herpes Simplex Virus-1 (HSV-1) IgGFA9051GFA9051G2026-06-08
00845533003674Herpes Simplex Virus-2 (HSV-2) IgMFA9052MFA9052M2026-06-08
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
00845533003568Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgGFA9151GFA9151G2026-05-26
00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15
00845533003537Alegria Flash GBM CL28151CL281512026-05-15