Witryna22 gru 2024 · The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal or Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of oxycodone in human oral fluid with … WitrynaThe format and organization of the information on the CoA is at the issuing laboratory’s discretion. The CoA can be printed on letterhead with the logo of the issuing …
Certificate of analysis - Wikipedia
WitrynaIMMUNALYSIS CORPORATION MICHELLE BODIEN, ASSOCIATE DIRECTOR, REGULATORY AFFAIRS 829 TOWNE CENTER DRIVE POMONA, CA 91767 Re: k161216 Trade/Device Name: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay and Immunalysis Fentanyl Urine Calibrators Regulation Number: 21 … WitrynaImmunalysis Oxycodone Urine Calibrators: The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme … how to save bookmarks folder
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION - Food and Drug Administration
WitrynaImmunalysis Corporation 829 Towne Center Drive, Pomona, CA 91767. Toll Free: +1 888-664-TEST (8378) Canada & US Only; Phone: +1 909-482-0840; FAX: +1 909-482-0850; E-mail: [email protected]; Contact Us Online. Order; Product Support; Certificates of Analysis and Kit Inserts; Safety Data Sheets; Witryna23 lis 2024 · Purpose and Benefits. The main purpose of a COA is to assure customers, manufacturers, and suppliers that the product they are dealing with meets their agreed-upon standards. The COA is provided by the manufacturer and it is based on their capabilities and internal quality standards, the customers’ needs and targets, and, if … WitrynaNo discrepancy was found between oxycodone DRI assay and Immunalysis enzyme immunoassay (EIA). Cannabinoids EMIT II Plus assay performed better than DRI … how to save bookmarks in explorer