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AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION
Model 37312 · GERMAINE LABORATORIES, INC · DI 00695684373122
JJX — Single (Specified) Analyte Controls (Assayed And Unassayed) · Class I · 21 CFR 862.1660
NBW — System, Test, Blood Glucose, Over The Counter · Class II · 21 CFR 862.1345
UDILibrary device dossier · generated 2026-09-15 · 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
13.15
2019-02
0
17.95
2019-03
0
19.7
2019-04
0
25.95
2019-05
0
24.01
2019-06
0
21.7
2019-07
0
21.8
2019-08
0
20.56
2019-09
0
18.57
2019-10
0
20.47
2019-11
0
14.7
2019-12
0
17.62
2020-01
0
18.89
2020-02
0
17.05
2020-03
0
18.74
2020-04
0
16.4
2020-05
0
21.53
2020-06
0
27.12
2020-07
0
17.41
2020-08
0
11.5
2020-09
0
17.68
2020-10
0
11.72
2020-11
0
16.67
2020-12
0
16.94
2021-01
0
15.44
2021-02
0
15.81
2021-03
0
16.29
2021-04
0
17.51
2021-05
0
18.21
2021-06
0
18.08
2021-07
0
24.79
2021-08
0
15.99
2021-09
0
18.85
2021-10
0
18.04
2021-11
0
15.53
2021-12
0
21.94
2022-01
0
15.62
2022-02
0
14.07
2022-03
0
16.19
2022-04
0
14.82
2022-05
0
17.48
2022-06
0
14.06
2022-07
0
13.58
2022-08
0
7.79
2022-09
0
9
2022-10
0
7.87
2022-11
0
10.69
2022-12
0
7
2023-01
0
12.28
2023-02
0
9.21
2023-03
0
9.7
2023-04
0
7.5
2023-05
0
34.52
2023-06
0
21.72
2023-07
0
12.75
2023-08
0
10.71
2023-09
0
6.32
2023-10
0
6.37
2023-11
0
4.65
2023-12
0
4.3
2024-01
0
7.77
2024-02
0
2.73
2024-03
0
7.7
2024-04
0
3.99
2024-05
0
6.97
2024-06
0
4.74
2024-07
0
3.6
2024-08
0
3.25
2024-09
0
3.79
2024-10
0
4.2
2024-11
0
2.78
2024-12
0
5.52
2025-01
0
5.39
2025-02
0
2.64
2025-03
0
2.83
2025-04
0
3.51
2025-05
0
4.78
2025-06
0
3.14
2025-07
0
3.16
2025-08
0
4.51
2025-09
0
2.9
2025-10
0
3.6
2025-11
0
3.54
2025-12
0
2.65
2026-01
0
4.11
2026-02
0
2.36
2026-03
0
3.51
2026-04
0
3.03
2026-05
0
3.02
2026-06
0
4.14
This device (reports/month)Average device in JJX, NBW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — GERMAINE LABORATORIES, INC
VAI 2023-09-27 Germaine Laboratories, Inc · 5 citations
VAI 2023-09-27 Germaine Laboratories, Inc · 5 citations
NAI 2017-09-13 Germaine Laboratories, Inc · 0 citations
NAI 2017-09-13 Germaine Laboratories, Inc · 0 citations