Remove Containment Remove In-Vitro Remove Reagent
article thumbnail

Avacta Announces Collaboration Agreement With Bruker

The Pharma Data

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. 28, 2021 09:19 UTC. CAMBRIDGE & WETHERBY, England & BILLERICA, Mass.–(

Reagent 52
article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Transforming Biomanufacturing: Potential of Cell Free Systems

Roots Analysis

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. Additionally, these types of cell free systems do not contain proteases and nucleases as crude cell lysates, which further helps in improving the production of many proteins.

Protein 52
article thumbnail

It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2

FDA Law Blog

We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation. a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis.

article thumbnail

Rising Demand for DNA and Gene Cloning  Service Providers

Roots Analysis

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. There are some motifs, such as hairpin loops which hinder the usability of a gene.

DNA 40