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

Antisera, Fluorescent, Human Metapneumovirus

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

OMG is the FDA product code for Antisera, Fluorescent, Human Metapneumovirus, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code 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 signs and symptoms of acute respiratory infection. This assay detects but is not...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OMG
Device name
Antisera, Fluorescent, Human Metapneumovirus
FDA definition
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 signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.
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
4
Ingested recalls
0

Clearances, product code OMG

By decision year
4 clearances under product code OMG with a decision year between 2009 and 2010, 2009 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OMG by decision year
YearClearances
20093
20101

Applicants with the most clearances

Product code OMG
Applicants holding the most 510(k) clearances under product code OMG
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.3
EMD Millipore Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code