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EliA IgM Conjugate 50
Model 83-0006-11 · Phadia AB · DI 07333066012964
JJY — Multi-Analyte Controls, All Kinds (Assayed) · Class I · 21 CFR 862.1660
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
3
2019-02
0
5.5
2019-04
0
3
2019-05
0
3.5
2019-06
0
7
2019-07
0
13.5
2019-09
0
2
2019-10
0
3
2019-11
0
4
2020-02
0
3
2020-03
0
2.71
2020-04
0
4
2020-05
0
8
2020-06
0
4
2020-07
0
4
2020-08
0
8
2020-09
0
7
2020-10
0
3.5
2020-11
0
3.5
2020-12
0
1
2021-01
0
4
2021-02
0
4
2021-03
0
3
2021-04
0
4
2021-05
0
3
2021-06
0
8
2021-07
0
2
2021-08
0
4
2021-09
0
4.25
2021-10
0
12.5
2021-11
0
3
2021-12
0
3
2022-01
0
4.5
2022-02
0
3.33
2022-03
0
4
2022-04
0
4
2022-05
0
4
2022-06
0
3.5
2022-07
0
4
2022-08
0
7
2022-10
0
5.5
2022-11
0
2
2022-12
0
9
2023-01
0
4
2023-02
0
2
2023-03
0
5
2023-04
0
7
2023-05
0
4.33
2023-06
0
1.5
2023-07
0
7
2023-08
0
5.25
2023-09
0
12
2023-10
0
6.5
2023-11
0
6
2023-12
0
3
2024-01
0
5.5
2024-02
0
6
2024-03
0
6
2024-04
0
8
2024-05
0
13
2024-06
0
11.5
2024-07
0
8
2024-08
0
6
2024-09
0
24.5
2024-10
0
8
2024-11
0
11
2024-12
0
10
2025-01
0
9.5
2025-02
0
9.5
2025-03
0
9.18
2025-04
0
17
2025-05
0
20
2025-06
0
9.5
2025-07
0
29.5
2025-08
0
9.5
2025-09
0
12.5
2025-10
0
4.25
2025-11
0
4
2025-12
0
6.5
2026-01
0
15.5
2026-02
0
3
2026-03
0
69
2026-04
0
20
2026-05
0
12
2026-06
0
5.67
This device (reports/month)Average device in JJY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K091845 — cites (transitively): K020752 (d1), K020758 (d1), K040449 (d1), K092983 (d1) — cited as predicate by K151799, K182747
Lineage extracted from public 510(k) summary text (heuristic).