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Areta Multi-Drug Test Cup (25 tests kit)
Model ACDOA-1144 · EASY HEALTHCARE CORPORATION · DI 00810038630649
CAF — Nebulizer (Direct Patient Interface) · Class II · 21 CFR 868.5630
DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Class II · 21 CFR 862.3250
DIS — Enzyme Immunoassay, Barbiturate · Class II · 21 CFR 862.3150
DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650
DJR — Enzyme Immunoassay, Methadone · Class II · 21 CFR 862.3620
DKZ — Enzyme Immunoassay, Amphetamine · Class II · 21 CFR 862.3100
JXM — Enzyme Immunoassay, Benzodiazepine · Class II · 21 CFR 862.3170
JXN — Enzyme Immunoassay, Propoxyphene · Class II · 21 CFR 862.3700
LAF — Gas Chromatography, Methamphetamine · Class II · 21 CFR 862.3610
LCM — Enzyme Immunoassay, Phencyclidine
LDJ — Enzyme Immunoassay, Cannabinoids · Class II · 21 CFR 862.3870
LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs · Class II · 21 CFR 862.3910
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.12
2019-02
0
1
2019-03
0
1
2019-04
0
2.5
2019-05
0
1
2019-06
0
1
2019-07
0
1
2019-09
0
1
2019-10
0
1.89
2019-11
0
1
2019-12
0
1
2020-01
0
1.75
2020-02
0
2
2020-03
0
1
2020-04
0
1.5
2020-07
0
1.5
2020-08
0
1
2020-09
0
1
2020-10
0
1
2020-11
0
1
2020-12
0
1.5
2021-01
0
1.5
2021-02
0
3.25
2021-03
0
1.5
2021-04
0
3.71
2021-05
0
1
2021-06
0
1.67
2021-07
0
6.75
2021-08
0
3.6
2021-09
0
1
2021-10
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
2
2022-02
0
1
2022-03
0
1.5
2022-04
0
1.33
2022-05
0
4.33
2022-06
0
1.18
2022-07
0
1
2022-08
0
1
2022-09
0
2.08
2022-10
0
1.5
2022-11
0
2
2022-12
0
2
2023-01
0
1.67
2023-02
0
1.8
2023-03
0
2
2023-04
0
2
2023-05
0
1.67
2023-06
0
1.5
2023-07
0
2.57
2023-08
0
2
2023-10
0
1.25
2023-11
0
1.38
2023-12
0
2.5
2024-01
0
1.33
2024-02
0
2.67
2024-03
0
1.75
2024-04
0
3
2024-05
0
1.6
2024-06
0
4
2024-07
0
1.38
2024-08
0
3
2024-09
0
2.2
2024-10
0
5.73
2024-11
0
3
2024-12
0
1.92
2025-01
0
3.14
2025-02
0
2.63
2025-03
0
1.67
2025-04
0
2
2025-05
0
2.63
2025-06
0
3.2
2025-07
0
1.25
2025-08
0
4
2025-09
0
3
2025-10
0
3.8
2025-11
0
3.25
2025-12
0
4.67
2026-01
0
5.5
2026-02
0
7.25
2026-03
0
11.2
2026-04
0
9.25
2026-05
0
20.67
2026-06
0
11.17
This device (reports/month)Average device in CAF, DIO, DIS, DJG, DJR, DKZ, JXM, JXN, LAF, LCM, LDJ, LFG (reports/device/month)