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Devices
Device Recall UCG BetaSlide Monoclonal II
Model / Serial
Code number 16B4; lot numbers 0224099, Exp. 7/9/2010; 0618299, Exp 10/30/2010; 0818039, Exp. 1/11/2011 and 1010168, Exp. 3/20/2010.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Nationwide and to Australia
Product Description
UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.
Manufacturer
Inverness Medical Professional Diagnostics
1 Event
Recall of Device Recall UCG BetaSlide Monoclonal II
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Manufacturer
Inverness Medical Professional Diagnostics
Manufacturer Address
Inverness Medical Professional Diagnostics, 2 Research Way, Princeton NJ 08540-6628
Source
USFDA
Language
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