HIVEBENCH FDA COMPLIANCE MANUALS

Analyte Specific Reagent (ASR) For tests using a manufacturer labeled Analyte Specific Reagent (ASR) as the reagent providing the specificity of the assay (previously referred to as Compliance Statement A). LabArchives is the leading research data management SaaS application platform dedicated to better science used by more than 600,000 scientists to manage research data, inventories, and laboratory resources. The FDA website states: Not only do these products contain undisclosed drug.

HIVEBENCH FDA COMPLIANCE MANUALS

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. For tests that use an FDA approved/cleared/exempt IVD that has been modified from the manufacturer’s instructions. The Compliance Program Manuals (CPM) provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws. Moreover, automatic sign-outs are a feature of Hivebench. Researchers who use Hivebench can securely share their work with their colleagues. It also complies with FDA/funder requirements. In contrast to this, Hivebench uses universal templates to share results in a consistent manner. eLabJournal Cloud is an off-the-shelf configurable Electronic Lab Notebook (ELN) that is the best solution for customers that do not have the budget or resources to invest in hardware and system maintenance. There is also no uniform format for sharing.

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. Aside from this, paper laboratory notebooks cannot comply with funders/FDA.

Hivebench fda compliance