OUSClass I

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

21 CFR 866.2050 / Microbiology

OUS is the FDA product code for Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt, a class I device type, regulated under 21 CFR 866.2050. FDA's definition for this code reads: "The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2012-03-30, and no recalls.

Classification record

Product code: OUS
Device name: Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
FDA definition: The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.
Regulation: 21 CFR 866.2050
Device class: Class I
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code OUS

By decision year

2 clearances under product code OUS with a decision year between 2011 and 2012, 2011 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OUS by decision year
Year	Clearances
2011	1
2012	1

Applicants with the most clearances

Product code OUS

Applicants holding the most 510(k) clearances under product code OUS
Applicant	Clearances
Microphage, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OUS.

Recent clearances

Product code OUS

Recent recalls

Product code OUS

FDA records show no recalls under product code OUS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)