Submit Professional and Prescription Self-Test COVID-19 Rapid Antigen tests for Emergency Use Authorization
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 1 Mar 2021
- Due
- 31 Mar 2021
- Delivered
- Q1 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“OraSure plans to submit both a Prescription Self-Test and a Professional Test for EUA in Q1”
What we found
Evidence strength A What the grades mean
A May 2021 8-K says the EUA application for both prescription home and professional use was submitted in Q1 2021, meeting the Q1 deadline.
-
A Orasure Technologies Inc. 8-K filed 2021-05-05
“EUA Application Submitted in Q1 to FDA for COVID-19 Rapid Antigen Test for Both Prescription Home Use and Professional Use in Point of Care Settings” ✓ confirmed on the page
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A Orasure Technologies Inc. 8-K filed 2021-05-05
“OraSure has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen test for both Prescription Home Use, and Professional Use in point of care (POC) CLIA-waived settings.” ✓ confirmed on the page
Checked 26 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- EUA submissions for Professional and Prescription Self-Test
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-OSUR-024933 · Corrections policy