WebJun 16, 2024 · The customers will then add their own chemistry and perform calibration of the instruments. These plates are sold separately, NOT as part of the instrument system. As no chemistry inside, the "General Purpose Reagent" label is not applicable. If I label as … Web2. Reagent High purity generally equal to A.C.S. grade and suitable for use in many laboratory and analytical applications. 3. U.S.P. A chemical grade of sufficient purity to meet or exceed requirements of the U.S. Pharmacopeia (USP); acceptable for food, drug, or medicinal use; may be used for most laboratory purposes. 4. N.F.

Product Classification - Food and Drug Administration

Webd. to monitor therapeutic measures,and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its product owner to be used for in vitro diagnostic examination. Label – a written, printed or graphic information provided upon the IVD itself ... WebSep 16, 2024 · General Usage Procedure of Laboratory Reagents / Chemicals: The analyst shall take the required reagent for usage from its designed storage place/ chemical store. The analyst shall put the date of opening with signature and expiry date on the label affixed at the time of receipt. If the label is not affixed, Do not use such reagents. isaac a gift from above

Guidance Document - Labelling of In Vitro Diagnostic Devices

WebJan 17, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use. (a) Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is … Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the … See more The FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an … See more IVDs, and all other medical devices, are subject to General Controls, unless expressly exempt per the statute or regulations. General Controls are the basic provisions (authorities) of the May 28, 1976 Medical … See more A general purpose reagent (GPR) is "a chemical reagent that has general laboratory application, is used to collect, prepare, and examine specimens from the human body for … See more Analyte specific reagents (ASRs) are "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents … See more WebJan 17, 2024 · (d) The labeling of general purpose laboratory reagents (e.g., hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose uses are generally known by persons trained in their use need not bear the directions for use required by § 809.10(a) and (b), if their labeling meets the requirements of this paragraph. isaac afterbirth plus updates