FDA-Device2016-08-03Class III
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Alere San Diego, Inc.
Hazard
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Sold states
US
Affected count
N/A
Manufactured in
9975 Summers Ridge Rd, N/A, San Diego, CA, United States
Products
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2016Don't want to check this manually?
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