Device
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...
Manufacturer
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
Model: CL28141
Catalog: CL28141
DI: 00845533003490
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c9470f51-a770-49ae-92aa-a87e1a446785
Distribution Status:
In Commercial Distribution
DUNS Number:
080953946
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00845533003490
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59066
Name: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay
Definition:
A 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.
FDA Product Codes
None
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature