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Immunoassay For Detection Of Amniotic Fluid Protein(S).
FDA product code NQM · Class 1 · Clinical Chemistry
9
Registered devices
41
Adverse events
3
Recalls
2
510(k) clearances
Devices with this code
ROM Plus®, Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus, Complete Kit Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus, Complete Kit Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus®, Fetal Membranes Rupture Collection Kit — CLINICAL INNOVATIONS, LLCROM Plus®, Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus®, Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus, Complete Kit Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus, Complete Kit Fetal Membranes Rupture Test — CLINICAL INNOVATIONS, LLCROM Plus, Quality Control for Fetal Membranes Rupture Tes — CLINICAL INNOVATIONS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-13 | Clinical Innovations, LLC | Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnosti |
| 2020-02-21 | Qiagen Sciences LLC | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. |
| 2018-05-18 | Qiagen Sciences, Inc. | Potential for control line not appearing on the test strip |
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