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

Molecular Erythrocyte Typing Test

Unknown
FDA source (opens on fda.gov)

PEP is the FDA product code for Molecular Erythrocyte Typing Test, a class III device type. FDA's definition for this code reads: "Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PEP
Device name
Molecular Erythrocyte Typing Test
FDA definition
Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
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