2 results
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8ms
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Sources: EU EUDAMED, US FDA
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·November 11, 2015
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022