FDA product code PEP: Molecular Erythrocyte Typing Test
PEP is the FDA product code for molecular erythrocyte typing test. It is a Class III device, reviewed by the Hematology panel. Devices under PEP reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PEP devices, 1 initiated in the last five years.
Definition
Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
Classification
| Field | Value |
|---|---|
| Device name | Molecular Erythrocyte Typing Test |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PEP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-02-15.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code PEP?
PEP is the FDA product code for molecular erythrocyte typing test. It is a Class III device, reviewed by the Hematology panel.
What device class is PEP?
Class III. Typical premarket route: PMA.
Have PEP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code PEP
- Run a recall and safety report across every PEP manufacturer
- Watch product code PEP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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