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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
VITROS — ORTHO CLINICAL DIAGNOSTICSSerum CrossLaps® (CTX-I) ELISA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDElecsys Beta-CrossLaps/serum — Roche Diagnostics GmbHNTx Serum — ZEUS SCIENTIFIC, INC.Alpha CrossLaps® (CTX-I) EIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDElecsys CrossLapsserum Immunoassay — Roche Diagnostics GmbHZEUS NTx Urine — ZEUS SCIENTIFIC, INC.IDS Beta CrossLaps® (CTX-I) — IMMUNODIAGNOSTIC SYSTEMS LIMITEDZEUS NTx Serum — ZEUS SCIENTIFIC, INC.MicroVue — QUIDEL CORPORATIONSebia NTx Serum Test System — ZEUS SCIENTIFIC, INC.IMMULITE®/IMMULITE® 1000 Systems DPD Pyrilinks-D Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® Systems PDP CONTROL Pyrilinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys ?-CrossLaps/serum — Roche Diagnostics GmbHVITROS — ORTHO CLINICAL DIAGNOSTICSUrine CartiLaps ® (CTX-II) EIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDUrine BETA CrossLaps® (CTX-I) ELISA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDZEUS NTx Serum — ZEUS SCIENTIFIC, INC.IMMULITE® 2000 Systems DPD Pyrlinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMicroVue — QUIDEL CORPORATIONElecsys Beta-CrossLaps/serum — Roche Diagnostics GmbHOsteomark NTx Serum — Alere Scarborough, Inc.Elecsys CrossLaps CalSet — Roche Diagnostics GmbH
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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