FDA.reportPublic FDA data

APL™ IgM ELISA Kit

Primary DI
B473LAPLKAPM00
Brand
APL™ IgM ELISA Kit
Company
Louisville APL Diagnostics, Inc.
Model
IgM
Catalog number
LAPL-K-AP-M-0
Device description
The APL™ IgM ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgM isotype.
Published
2022-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B473LAPLKAPM00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antiphospholipid antibodies associated with antiphospholipid syndrome, in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
018417647
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
B473LAPLKAPA00APL™ IgA ELISA Kit IgALAPL-K-AP-A-0 2022-12-26
B473LAPLKAPG00APL™ IgG ELISA Kit IgGLAPL-K-AP-G-0 2022-12-26
B473LAPLKHRP001G0APhL ELISA® IgG HRP KitIgGLAPL-K-HRP-001G2022-12-26
B473LAPLKHRP001M0APhL ELISA® IgM HRP KitIgMLAPL-K-HRP-001M2022-12-26
B473LAPLKHRPAB2GPI1A0LAPL™ aB2GPI IgA HRP ELISA Kit IgALAPL-K-HRP-AB2GPI-1A2022-12-26
B473LAPLKHRPAB2GPI1G0LAPL™ aB2GPI IgG HRP ELISA Kit IgGLAPL-K-HRP-AB2GPI-1G 2022-12-26
B473LAPLKHRPAB2GPI1M0LAPL™ aB2GPI IgM HRP ELISA Kit IgMLAPL-K-HRP-AB2GPI-1M2022-12-26
B473LAPLKHRP00GM0APhL ELISA® IgG and IgM HRP KitIgG and IgMLAPL-K-HRP-00GM2017-02-06