Panels › Clinical Chemistry › Product code NQM · Class 1
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Regulation 862.1550
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NQM
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Innovations, LLC | 1 | 1 |
| Qiagen Sciences LLC | 0 | 2 |
| Amnisure International, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2020 | Clinical Innovations, LLC Clinical Innovations ROM Plus Collection Kit
IFU:
ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Terminated |
NQM | K110605 |
| Feb 21, 2020 | Qiagen Sciences LLC AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) Terminated |
NQM | K081767 |
| Jul 13, 2018 | Qiagen Sciences, Inc. AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA
Product Usage:
Rapid, non-instrumented, qualitative immunochromatographic test for the in Terminated |
NQM | K081767 |
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