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CorDx Tyfast
Model ACT21003-10 · CORETESTS, INC. · DI 00850042559949
QYT — Over-The-Counter Covid-19 Antigen Test · Class II · 21 CFR 866.3984
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)
2021-05
0
3
2021-06
0
4
2021-07
0
29
2021-08
0
48
2021-09
0
65
2021-10
0
19
2021-11
0
24
2021-12
0
44
2022-01
0
30
2022-02
0
15.33
2022-03
0
11.5
2022-04
0
19
2022-05
0
20.5
2022-06
0
15.25
2022-07
0
14
2022-08
0
13
2022-09
0
22
2022-10
0
44
2022-11
0
39.33
2022-12
0
30
2023-01
0
54.5
2023-02
0
26
2023-03
0
34.5
2023-04
0
45
2023-05
0
35
2023-06
0
18
2023-07
0
17
2023-08
0
20
2023-09
0
14.67
2023-10
0
75
2023-11
0
58
2023-12
0
17.67
2024-01
0
32
2024-02
0
31.5
2024-03
0
14
2024-04
0
6
2024-05
0
4
2024-06
0
1.5
2024-07
0
6
2024-08
0
7.75
2024-09
0
4
2024-10
0
5
2024-11
0
2.75
2024-12
0
5.5
2025-01
0
6.75
2025-02
0
1.5
2025-03
0
4.5
2025-04
0
3
2025-05
0
1
2025-06
0
3
2025-07
0
1
2025-08
0
2
2025-09
0
1.5
2025-10
0
5
2025-11
0
5.5
2025-12
0
4
2026-01
0
2
2026-02
0
4
2026-03
0
3
2026-04
0
2
2026-05
0
2
This device (reports/month)Average device in QYT (reports/device/month)
Regulatory clearances
K240728 SESE 2024-06-21 (k number procode)
Predicate lineage
K240728 — cites (transitively): DEN220028 (d1), K230828 (d1) — cited as predicate by K251916
Lineage extracted from public 510(k) summary text (heuristic).