510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYBClass III

Kit, Rna Detection, Human Papillomavirus

Unknown
FDA source (opens on fda.gov)

OYB is the FDA product code for Kit, Rna Detection, Human Papillomavirus, a class III device type. FDA's definition for this code reads: "For the detection of human papillomavirus RNA to aid in assessing risk of cancer". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OYB
Device name
Kit, Rna Detection, Human Papillomavirus
FDA definition
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code