APL IGA ELISA KIT
LOUISVILLE APL DIAGNOSTICS, INC.
LOUISVILLE APL DIAGNOSTICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1529254 | 1000305932 | LOUISVILLE APL DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 702 9TH ST N STE A Texas City TX US 77590 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 47998 | 1242455167 | K933588 | APHLELISA KIT | MID | 1994-10-13 |
| 47998 | 1810283725 | K021398 | APL IGA ELISA KIT | MID | 2002-08-27 |
| 47998 | 1288198872 | K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | MSV | 2001-09-28 |
| 47998 | 1429347031 | K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | MSV | 2001-09-28 |
| 47998 | 1663632441 | K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | MSV | 2001-09-28 |
Product Codes Associated With Registrations#
PMN#
ACL/APS FACS KIT
LOUISVILLE APL DIAGNOSTICS, INC.
APHLELISA KIT
LOUISVILLE APL DIAGNOSTICS, INC.
GUDID#
APL™ IgA ELISA Kit - The APL™ IgA ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgA isotype.
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LAPL™ aB2GPI IgM HRP ELISA Kit - LAPL™ aB2GPI IgM HRP ELISA Kit for detection of IgM anti-B2 Glycoprotein I Antibodies.
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APhL ELISA® IgG and IgM HRP Kit - APhL ELISA® IgG and IgM HRP Kit For the Measurement of IgG and IgM Antiphospholipid Antibodies
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