Device
The Alegria Flash GBM kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to GBM in human serum. It is intended for use...
Manufacturer
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
Model: CL28151
Catalog: CL28151
DI: 00845533003537
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 GBM kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to GBM in human serum. It is intended for use as an aid in the diagnosis of Goodpasture’s Syndrome 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:
8d146dac-3c77-4bc8-96b3-280f3af3b6d3
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:
00845533003537
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59065
Name: Glomerular basement membrane antibody (Goodpasture antibody) 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 antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a chemiluminescent immunoassay method.
FDA Product Codes
None