Regulatory Affairs Associate I, II, or III

Regulatory Affairs/In Vitro Diagnostics Associate will be assisting with all aspects of regulatory functions, including: regulatory assessments, maintenance of regulatory files, compliance with design control procedures, adherence to national and international regulations. In addition this individual will assist with 510(k)…
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Regulatory Affairs Manager

Summary of Responsibilities Regulatory Affairs/In Vitro Diagnostics Manager will be responsible for managing Design Control process, device validations and verifications, clinical trials, 510(k) and other regulatory submissions. In addition, the Regulatory Manager will be responsible for license renewals, periodic regulatory…
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Is There a Reason to Test Both Serum and Urine for Histoplasma Antigen?

QUESTION: Is there a reason to test both urine and serum for Histoplasma antigen [1]? CASE REPORT: A healthy 24-year-old man cleaned the gutters on his 16-year-old fishing cabin on a lake in Wisconsin. He presented for medical evaluation 12…
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Medical Technologist/Medical Laboratory Scientist M-F 8-5

Responsible for performing clinical assays, maintaining quality assurance of assays, verifying and relaying results, and performing tasks associated with support of clinical tests and as required by MiraVista Policies/Procedures and 42CFR 493.1489, 493.1495 and Part 58-1 of 10NYCRR. Essential Duties…
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Are You Underdiagnosing Coccidioidomycosis?

Are You Underdiagnosing Coccidioidomycosis? Capture Additional Cases with Combined Antigen and Antibody Testing. Dear Colleagues, The prevailing method for diagnosis of coccidioidomycosis is serum antibody testing by immunodiffusion (ID) with a sensitivity of 84.2% and specificity of 96.5%, but a…
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Test Report Updates for 2020

In order to maintain good business practices, MiraVista Diagnostics is providing a 90-day notice of pending updates to our test report format to our referral testing customers. Minor changes have been made to the layout, while critical information such as…
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MiraVista COVID-19 Announcement

MiraVista is open and continues to provide critical diagnostic testing despite the impact COVID-19 has had on staffing. The health and welfare of our team is of critical importance. To limit the opportunity of exposure to COVID-19 for our entire…
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MiraVista Diagnostics LLC has formed an Institutional Biosafety Committee (IBC)

In compliance with the National Institutes of Health Office of Science Policy (NIH OSP), MiraVista Diagnostics LLC has formed an Institutional Biosafety Committee (IBC) to review, approve and confirm that the company’s research involving recombinant/synthetic DNA complies with NIH guidelines….
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Diagnosis of Histoplasma Meningitis by Combined Testing for Antigen and IgG & IgM Antibody in Cerebrospinal Fluid

BACKGROUND: Central nervous system (CNS) histoplasmosis often goes unrecognized, delaying diagnosis and treatment, resulting in neurologic complications or death. It occurs in 5% to 10% of patients with disseminated histoplasmosis, and despite clinical suspicion of CNS involvement, laboratory confirmation can…
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Diagnosis of Progressive Disseminated Histoplasmosis (PDH)

Background. Culture is the gold standard for diagnosis [1] and the sensitivity ranges from about 60 to 80% [2-5] (Table 1). However, growth of Histoplasma is slow, taking up to six weeks and culture rarely provides the initial basis for…
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