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Devices
Device Recall Legionella ELISA Test System
Model / Serial
Lot # 91803Z and 30804/30804Z
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to Domestic customers only.
Product Description
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
Manufacturer
Diamedix Corporation
1 Event
Recall of Device Recall Legionella ELISA Test System
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Manufacturer
Diamedix Corporation
Manufacturer Address
Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
Source
USFDA
Language
English
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