510(k) K091171

D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT by Diagnostic Hybrids, Inc. — Product Code OMG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 11, 2009
Date Received: April 22, 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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K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (December 23, 2009)
K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (December 4, 2009)
K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (October 21, 2009)
K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)
K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (March 6, 2009)
K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)

510(k) K091171

Clearance Details

Device Classification

Other clearances by Diagnostic Hybrids, Inc.

Other clearances for product code OMG