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LOUISVILLE APL DIAGNOSTICS, INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
APhL ELISA® IgM HRP Kit	IgM	FDA UDI	N/A	Active
APL™ IgG ELISA Kit	IgG	FDA UDI	N/A	Active
APL™ IgM ELISA Kit	IgM	FDA UDI	N/A	Active
APhL ELISA® IgG HRP Kit	IgG	FDA UDI	N/A	Active
LAPL™ aB2GPI IgA HRP ELISA Kit	IgA	FDA UDI	N/A	Active
LAPL™ aB2GPI IgM HRP ELISA Kit	IgM	FDA UDI	N/A	Active
APL™ IgA ELISA Kit	IgA	FDA UDI	N/A	Active
LAPL™ aB2GPI IgG HRP ELISA Kit	IgG	FDA UDI	N/A	Active
APhL ELISA® IgG and IgM HRP Kit	IgG and IgM	FDA UDI	N/A	Active
Aphlelisa Kit	K933588	FDA 510(k)	Class II	Active
Acl/Aps Facs Kit	K984102	FDA 510(k)	Class II	Active
Apl Iga Elisa Kit	K021398	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 18, 2006	Z-0034-2008	—	terminated	Product mislabeled; outer container labeled with incorrect lot number.
Oct 6, 2005	Z-1176-2007	—	terminated	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Oct 6, 2005	Z-1177-2007	—	terminated	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Oct 6, 2005	Z-1175-2007	—	terminated	Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Aug 10, 2004	Z-1104-2007	—	terminated	Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
Aug 10, 2004	Z-1103-2007	—	terminated	Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.