BD Affirm™ Vpiii Microbial Identification Test
Catalogue number 446252, listed by Becton, Dickinson AND Company, United States, under Dna Probe, Trichomonas Vaginalis. 1 manufacturer in China is registered for this product code.
Dna Probe, Trichomonas Vaginalis
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
What Is FDA Product Code MJK?
Dna Probe, Trichomonas Vaginalis is FDA product code MJK, Class 1, 21 CFR 866.2660.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 6 recalls under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Employee error (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record