FDA.reportPublic FDA data

Alegria Flash GBM Control Kit

Primary DI
00845533003544
Brand
Alegria Flash GBM Control Kit
Company
ZEUS SCIENTIFIC, INC.
Model
CL28151CK
Catalog number
CL28151CK
Device 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.
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
00845533003544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003544008455330035448455330035440845533003544

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture antibody) IVD, controlA 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.

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
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00845533003537Alegria Flash GBM CL28151CL281512026-05-15
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00845533002868Anti-SARS-CoV-2 TotalSM9Z7901SM9Z79012026-04-01
00845533003100Anti-dsDNA2Z2881G2Z2881G2026-04-01
00845533003117Anti-dsDNASM2Z2881GSM2Z2881G2026-04-01
00845533003124Anti-EBV EA IgG9Z9481G9Z9481G2026-04-01
00845533003131Anti-EBV EA IgGSM9Z9481GSM9Z9481G2026-04-01
00845533003148ENA Screen2Z2851G2Z2851G2026-04-01
00845533003155ENA ScreenSM2Z2851GSM2Z2851G2026-04-01
00845533003162Anti-Gliadin IgA2Z61001A2Z61001A2026-04-01
00845533003179Anti-Gliadin IgASM2Z61001ASM2Z61001A2026-04-01