Device
The Alegria Flash PR3 Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash PR3 kit. The perfor...
Manufacturer
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
Model: CL28141CK
Catalog: CL28141CK
DI: 00845533003506
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 Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash PR3 kit. The performance characteristics of the Alegria Flash PR3 Control Kit have not been established for any other assays or instrument platforms.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
282878c8-f308-4ff8-bec9-9059525e8d3f
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:
00845533003506
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55074
Name: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, reagent
Definition:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen.
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