510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103207Substantially Equivalent

Jbaids Q Fever Detection Kit

Idaho Technology, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103207 is the FDA 510(k) clearance record for JBAIDS Q FEVER DETECTION KIT, a class I device, cleared for Idaho Technology, Inc. on under FDA product code OVF (Assay, Direct, Nucleic Acid Amplification, Q Fever). FDA's definition for product code OVF reads: "These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological...". FDA records list 8 510(k) clearances for Idaho Technology, Inc., from to . As of , FDA records show no recalls naming K103207.

Clearance record

Decision date
Received
(200 days to decision)
Product code
OVF Assay, Direct, Nucleic Acid Amplification, Q Fever
Regulation
21 CFR 866.3500
Device class
Class I
Review panel
Microbiology
Applicant
Idaho Technology, Inc. 390 Wakara Way, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVF

Trailing 12 months

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

FDA records show no clearances under product code OVF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OVF, 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