510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190025Unknown

OraQuick Ebola Rapid Antigen Test

OraSure Technologies, Inc., Bethlehem PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190025 is the FDA 510(k) clearance record for OraQuick Ebola Rapid Antigen Test, a class II device, cleared for OraSure Technologies, Inc. on under FDA product code QID (Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens). FDA's definition for product code QID reads: "A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs...". FDA records list 30 510(k) clearances for OraSure Technologies, Inc., from to . As of , FDA records show no recalls naming DEN190025.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Regulation
21 CFR 866.4002
Device class
Class II
Review panel
Microbiology
Applicant
OraSure Technologies, Inc. 220 E. First St., Bethlehem PA
Third party review
No

Clearances, product code QID

Trailing 12 months

FDA records hold no clearances under product code QID in the trailing twelve months.

FDA records show no clearances under product code QID in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QID, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260