Device
The Alegria Flash GBM Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash GBM assay kit. The...
Manufacturer
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
Model: CL28151CK
Catalog: CL28151CK
DI: 00845533003544
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 Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash GBM assay kit. The performance characteristics of the Alegria Flash GBM 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:
c8d788aa-2119-4f7b-ac0f-cfeb3d8e043b
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:
00845533003544
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 54955
Name: Glomerular basement membrane antibody (Goodpasture antibody) IVD, control
Definition:
A material which is used to verify the performance of an assay 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.
FDA Product Codes
None