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ARK™ HS Benzodiazepine II Assay

Model 5073-0001-02 · ARK DIAGNOSTICS INC · DI 00812101030493

JXM — Enzyme Immunoassay, Benzodiazepine · Class II · 21 CFR 862.3170

UDILibrary device dossier · generated 2026-09-11 · 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.

23562019-01: 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/device2019-12: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 3.5/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 6/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device010205060710121106030701041011010507081006
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
2019-1201
2021-1101
2022-0601
2023-0302
2023-0703.5
2024-0101
2024-0406
2024-1002
2024-1104
2025-0102
2025-0502
2025-0702
2025-0802
2025-1001
2026-0601
This device (reports/month)Average device in JXM (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