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510(k) K091753

ELVIS HSV ID AND D3 TYPING TEST SYSTEM by Diagnostic Hybrids, Inc. — Product Code GQL

K091753 is an FDA 510(k) premarket notification submitted by Diagnostic Hybrids, Inc. for the device "ELVIS HSV ID AND D3 TYPING TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 28, 2009. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Diagnostic Hybrids, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2009
Date Received
June 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Diagnostic Hybrids, Inc.

  • DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)
  • 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)
  • 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 GQL

  • K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (April 1, 2009)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K891162 — HSV-1 ELISA TEST SYSTEM (June 20, 1989)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)

FDA data resources