510(k) DEN140004

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY by Diagnostic Hybrids, Inc. — Product Code PGI

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 13, 2014
Date Received: February 21, 2014
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class: Class II
Regulation Number: 866.3309
Review Panel: MI
Submission Type

For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.

Other clearances by Diagnostic Hybrids, Inc.

K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
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)
K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (September 11, 2009)
K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (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)

Other clearances for product code PGI

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K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (December 20, 2023)
K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (November 26, 2019)
K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 2018)
K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (March 14, 2018)
K162451 — Solana HSV 1+2/VZV Assay (November 28, 2016)
K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol (October 6, 2015)
K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control (July 17, 2015)