International Medical Devices Database

Manufacturer Address
Louisville Apl Diagnostics Inc, 2622 NASA Parkway, Suite G2, Seabrook TX 77586-3447
Source
USFDA
2 Events
- Recall of IgM ELISA Kit
- Recall of IgG ELISA Kit

2 devices in the database

IgM ELISA Kit

Model / Serial
Lot #040531.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to a single direct account in CT.
Product Description
american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¿ aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.

IgG ELISA Kit

Model / Serial
Lot #040414.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to a single direct account in CT.
Product Description
american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¿ aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.

2 manufacturers with a similar name

Learn more about the data here

LOUISVILLE APL DIAGNOSTICS INC.

Manufacturer Address
SEABROOK
Manufacturer Parent Company (2017)
Louisville Apl Diagnostics Inc.
Source
HC

Louisville Apl Diagnostics Inc

Manufacturer Address
Louisville Apl Diagnostics Inc, 2622 Nasa Pkwy Ste G2, Seabrook TX 77586-3447
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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