Home › Device types › JMM
Column Chromatography & Color Development, Hydroxyproline
FDA product code JMM · Class 1 · Clinical Chemistry
28
Registered devices
6
Adverse events
2
Recalls
21
510(k) clearances
Devices with this code
NTx Urine — ZEUS SCIENTIFIC, INC.ZEUS NTx Serum — ZEUS SCIENTIFIC, INC.Sebia NTx Serum Test System — ZEUS SCIENTIFIC, INC.Elecsys CrossLaps CalSet — Roche Diagnostics GmbHMicroVue — QUIDEL CORPORATIONIDS-iSYS CTX-I (Crosslaps) — IMMUNODIAGNOSTIC SYSTEMS LIMITEDAlpha CrossLaps® (CTX-I) EIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDElecsys CrossLapsserum Immunoassay — Roche Diagnostics GmbHUrine BETA CrossLaps® (CTX-I) ELISA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDVITROS — ORTHO CLINICAL DIAGNOSTICSUrine CrossLaps® (CTX-I) EIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDSerum CrossLaps® (CTX-I) ELISA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDOsteomark NTx Serum — Alere Scarborough, Inc.ZEUS NTx Urine — ZEUS SCIENTIFIC, INC.IMMULITE® 2000 Systems DPD Pyrlinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDOsteomark NTx Urine — Alere Scarborough, Inc.IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSElecsys Beta-CrossLaps/serum — Roche Diagnostics GmbHElecsys ?-CrossLaps/serum — Roche Diagnostics GmbHIDS Beta CrossLaps® (CTX-I) — IMMUNODIAGNOSTIC SYSTEMS LIMITEDZEUS NTx Serum — ZEUS SCIENTIFIC, INC.IMMULITE® Systems PDP CONTROL Pyrilinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMicroVue — QUIDEL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-25 | Roche Diagnostics Operations, Inc. | Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-C |
| 2012-08-10 | Immunodiagnostics Systems Ltd | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sal |
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