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ARK™ Fentanyl II Assay

Model 5069-0001-00 · ARK DIAGNOSTICS INC · DI 00812101030561

DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device010205060710070604
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0501
2019-0601
2019-0701
2019-1002
2021-0701
2022-0601
2026-0401
This device (reports/month)Average device in DJG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ARK DIAGNOSTICS INC

  • NAI 2016-09-22 Ark Diagnostics, Inc. · 0 citations
  • NAI 2016-09-22 Ark Diagnostics, Inc. · 0 citations
  • NAI 2014-07-02 Ark Diagnostics, Inc. · 0 citations
  • NAI 2014-07-02 Ark Diagnostics, Inc. · 0 citations