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

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

21 CFR 866.3215 / Microbiology
FDA source (opens on fda.gov)

PRE is the FDA product code for Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PRE
Device name
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
FDA definition
A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code PRE

By decision year
4 clearances under product code PRE with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PRE by decision year
YearClearances
20171
20211
20231
20251

Applicants with the most clearances

Product code PRE
Applicants holding the most 510(k) clearances under product code PRE
ApplicantClearances
Immunexpress, Inc3
Inflammatix1

Companies listing this code with FDA

Companies whose registered establishments list this code