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

Human Metapneumovirus (Hmpv) Rna Assay System

21 CFR 866.3980 / Microbiology
FDA source (opens on fda.gov)

OEM is the FDA product code for Human Metapneumovirus (Hmpv) Rna Assay System, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OEM
Device name
Human Metapneumovirus (Hmpv) Rna Assay System
FDA definition
A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code OEM

By decision year
6 clearances under product code OEM with a decision year between 2008 and 2023, 2013 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OEM by decision year
YearClearances
20081
20111
20133
20231

Applicants with the most clearances

Product code OEM
Applicants holding the most 510(k) clearances under product code OEM
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.3
Gen-Probe Prodesse, Inc.2
Prodesse, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order