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CorDx Tyfast
Model ACT21002-5 · CORETESTS, INC. · DI 00850042559536
QMN — Covid-19 Multi-Analyte Antigen Device
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)
2022-03
0
187
2022-04
0
1078
2022-05
0
2196
2022-06
0
619
2022-07
0
75
2022-08
0
78
2022-09
0
50
2022-10
0
40
2022-11
0
22
2022-12
0
46
2023-01
0
49
2023-02
0
123
2023-03
0
285
2023-04
0
52
2023-05
0
8
2023-06
0
26
2023-07
0
8
2023-08
0
79
2023-09
0
63
2023-10
0
41
2023-11
0
57
2023-12
0
78
2024-01
0
57
2024-02
0
12
2024-03
0
27
2024-04
0
14
2024-05
0
5
2024-06
0
4
2024-07
0
5
2024-08
0
41
2024-09
0
8
2024-10
0
46
2024-11
0
17
2024-12
0
9
2025-01
0
30
2025-02
0
18
2025-03
0
15
2025-04
0
5
2025-05
0
12
2025-06
0
7
2025-08
0
6
2025-09
0
1
2025-10
0
1
2025-11
0
39
2025-12
0
13
2026-01
0
15
2026-02
0
18
2026-03
0
18
2026-04
0
22
2026-06
0
10
This device (reports/month)Average device in QMN (reports/device/month)