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System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA product code PHP · Class 3 · Unknown

92
Registered devices
32
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Home Page — EXACT SCIENCES CORPORATIONSTARlet Interface v2.2 — EXACT SCIENCES CORPORATIONCologuard Inhibitor Removal Tablet — EXACT SCIENCES CORPORATIONCologuard Hemoglobin Assay Wash — EXACT SCIENCES CORPORATIONNEU SLN Kit — EXACT SCIENCES CORPORATIONCG2 BND SLN — EXACT SCIENCES CORPORATIONCologuard Test Definition v1.3 — EXACT SCIENCES CORPORATIONEpi proColon — Epigenomics AGCONJ Kit — EXACT SCIENCES CORPORATIONCologuard Hemoglobin Bead Based Control Kit — EXACT SCIENCES CORPORATIONReader Control — EXACT SCIENCES CORPORATIONCologuard Spin Filter Kit — EXACT SCIENCES CORPORATIONCologuard Conversion Wash — EXACT SCIENCES CORPORATIONCAR SLN Kit — EXACT SCIENCES CORPORATIONMIX B Kit — EXACT SCIENCES CORPORATIONAnalysis Server v2.2 — EXACT SCIENCES CORPORATIONAnalytical Server — EXACT SCIENCES CORPORATIONCologuard Hemoglobin Bead Based Assay Wash — EXACT SCIENCES CORPORATIONCycler Control — EXACT SCIENCES CORPORATIONCNV WSH Kit — EXACT SCIENCES CORPORATIONAnalytical Client — EXACT SCIENCES CORPORATIONPRE WSH Kit — EXACT SCIENCES CORPORATIONCologuard ® Collection Kit — EXACT SCIENCES CORPORATIONCologuard Capture Wash Kit — EXACT SCIENCES CORPORATION

Recent recalls

DateFirmReason
2017-11-02Epigenomics AgThe diagnostic test kit may produce invalid test runs which may delay test results.
2017-04-28Exact Sciences CorporationExact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.