FDA.reportPublic FDA data

Alegria Flash MPO Control Kit

Primary DI
00845533003520
Brand
Alegria Flash MPO Control Kit
Company
ZEUS SCIENTIFIC, INC.
Model
CL28131CK
Catalog number
CL28131CK
Device description
The Alegria Flash MPO Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash MPO 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
00845533003520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003520008455330035208455330035200845533003520

GMDN Terms#

Term, Definition table
TermDefinition
Myeloperoxidase (MPO) 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 the enzyme myeloperoxidase (MPO) 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
Primary DIBrandModelCatalogPublished
00845533003681Herpes Simplex Virus-1 (HSV-1) IgMFA9051MFA9051M2026-06-09
00845533003698Herpes Simplex Virus-2 (HSV-2) IgGFA9052GFA9052G2026-06-09
00845533003582Alegria Flash SSA-60CL28001CL280012026-06-08
00845533003599Alegria Flash SSA-60 Control KitCL28001CKCL28001CK2026-06-08
00845533003605Alegria Flash SSA-52CL28011CL280112026-06-08
00845533003612Alegria Flash SSA-52 Control KitCL28011CKCL28011CK2026-06-08
00845533003629Alegria Flash SSBCL28021CL280212026-06-08
00845533003636Alegria Flash SSB Control KitCL28021CKCL28021CK2026-06-08
00845533003643Cytomegalovirus (CMV) IgGFA9001GFA9001G2026-06-08
00845533003650Cytomegalovirus (CMV) IgMmFA9001MFA9001M2026-06-08
00845533003667Herpes Simplex Virus-1 (HSV-1) IgGFA9051GFA9051G2026-06-08
00845533003674Herpes Simplex Virus-2 (HSV-2) IgMFA9052MFA9052M2026-06-08
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
00845533003568Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgGFA9151GFA9151G2026-05-26
00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003537Alegria Flash GBM CL28151CL281512026-05-15