6 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·December 4, 2013