Home / 510(k) Clearances / DEN140004

510(k) DEN140004

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

DEN140004 is an FDA 510(k) premarket notification submitted by Diagnostic Hybrids, Inc. for the device "QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY". The FDA issued a decision of De Novo Granted on May 13, 2014. The device falls under product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples), a Class II device regulated under 21 CFR 866.3309. Diagnostic Hybrids, Inc. has at least 10 other 510(k) clearances on record.

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)
  • 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)
  • K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)

Other clearances for product code PGI

  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • 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)

FDA data resources