Home / 510(k) Clearances / K120959

510(k) K120959

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT by Bio-Rad Laboratories — Product Code MXJ

K120959 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT". The FDA issued a decision of Substantially Equivalent on June 22, 2012. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
March 30, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Bio-Rad Laboratories

  • K183446 — BioPlex 2200 Lyme Total (March 12, 2019)
  • K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (February 13, 2019)
  • K180577 — BioPlex 2200 25-OH Vitamin D Kit (June 22, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I (May 19, 2017)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)

Other clearances for product code MXJ

  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K220923 — Elecsys HSV-1 IgG (08948844160) (October 12, 2022)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)
  • K143236 — Theranos Herpes Simplex Virus-1 IgG Assay (July 2, 2015)
  • K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (February 28, 2014)
  • K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (July 25, 2012)
  • K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM (April 26, 2011)
  • K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS (May 8, 2009)
  • K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (November 18, 2008)

FDA data resources