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System, Test, Tumor Marker, Monitoring, Bladder
FDA product code MMW · Class 2 · Immunology
17
Registered devices
6
Adverse events
1
Recalls
9
510(k) clearances
Devices with this code
NMP22 BladderChek Test — Alere Scarborough, Inc.Alere NMP22 BladderChek Test — Alere Scarborough, Inc.Bladder EpiCheck Test Kit — NUCLEIX LTDBTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCStatus BTA Card — PRINCETON BIOMEDITECH CORPORATIONBTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCBTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCBTA TRAK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCBTA TRAK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCBTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCStatus BTA Card — PRINCETON BIOMEDITECH CORPORATIONAlere NMP22 BladderChek Control Kit — Alere Scarborough, Inc.BTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCBTA stat — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCNMP22 BladderChek Control Kit — Alere Scarborough, Inc.Bladder EpiCheck Extraction Kit — NUCLEIX LTDAlere NMP22 BladderChek Test — Alere Scarborough, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-02-19 | Vysis | Some of the control slides did not have adequate cells deposited upon their surface. |
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