Epstein Index›Documents›EFTA00605649
💨IMPACT LEVEL 1 — MEH

Epstein File EFTA00605649: Submission and Pregnant (DS9)

General DocumentDate unavailableEFTA006056491 keyword hits
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This document references a Premarket Notification 510(k) submission to the FDA for a medical test detecting Simplex Viruses 1 and 2 and Group B Streptococcus. The excerpt indicates the submission is for FDA review but does not identify the submitting party, specific dates, or other relevant details about the medical device or test.

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🔑 Evidence Keywords
submissionpregnant

📋 Key Excerpts2

PersonKeyword
Excerpt 1
A Premarket Notification 510(k) **submission** for the test is being submitted shortly to FDA for review.
Excerpt 2
Simplex Viruses 1 and 2 in male and female genital and oral lesions and a test for the detection of Group B Streptococcus from enriched cultures taken from **pregnant**

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Source: U.S. Department of Justice

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