510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K091171Substantially Equivalent

D3 Ultra Duet Dfa Respiratory Virus Identification Kit

Ortho-Clinical Diagnostics, Inc., Athens OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091171 is the FDA 510(k) clearance record for D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT, a class II device, cleared for Diagnostic Hybrids, Inc. on under FDA product code OMG (Antisera, Fluorescent, Human Metapneumovirus). FDA's definition for product code OMG reads: "It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with...". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K091171.

Clearance record

Decision date
Received
(142 days to decision)
Product code
OMG Antisera, Fluorescent, Human Metapneumovirus
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Diagnostic Hybrids, Inc. 1055 E. State St., Suite 100, Athens OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMG

Trailing 12 months

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

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