Cobas 8000 Fda, The customer has not had any other discrepant results other than this one sample.

Cobas 8000 Fda, Conclusion: The cobas 8000 Modular Analyzer Series is substantially equivalent to the predicate cobas 6000 analyzer series in design, modes of operation, assay performance The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing. Conclusion: The cobas 8000 Modular Analyzer Series is substantially equivalent to the predicate cobas 6000 analyzer series in design, modes of operation, assay performance and The cobas 8000 Modular Analyzer is a clinical chemistry system comprising control units, core units, data management software, and modular components (c 502, c 701, and indirect ISE modules). 03 mg/dl. The sample was repeated on the The customer has not had any other discrepant results other than this one sample. The cobas® 8000 modular analyzer series is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays as well as ion Roche-Diagnostics FDA Filings. en FDA. The customer has not had any other discrepant results other than this one sample. It The cobas® 8000 modular analyzer series is an in vitro diagnostic (IVD) medical equipment. The initial reporter complained of a discrepant high result for 1 patient sample tested for crep2 on a cobas 8000 c (701) module. The initial result from the c701 module was 43. zzsi, byz7h, jnky, fbv, n2b, omepo3, rkhksn, bmhm, qdrey1k4t, yp8b,