510(k) K090073

D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT by Diagnostic Hybrids, Inc. — Product Code OMG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 6, 2009
Date Received: January 12, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antisera, Fluorescent, Human Metapneumovirus
Device Class: Class II
Regulation Number: 866.3980
Review Panel: MI
Submission Type

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.

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510(k) K090073

Clearance Details

Device Classification

Other clearances by Diagnostic Hybrids, Inc.

Other clearances for product code OMG