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510(k) K911570

EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST by Ortho Diagnostic Systems, Inc. — Product Code MCD

K911570 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST". The FDA issued a decision of Substantially Equivalent on June 10, 1991. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
April 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ebv, Capsid
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Ortho Diagnostic Systems, Inc.

  • K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (July 14, 1997)
  • K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (March 6, 1997)
  • K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (January 22, 1997)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 10, 1996)
  • K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTE (May 9, 1996)
  • K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (April 30, 1996)

Other clearances for product code MCD

  • K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYM (January 11, 1999)
  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)
  • K924091 — EBV-VCA IGG ELISA TEST SYSTEM (January 11, 1993)
  • K920412 — MODIFIED ORTHO EBV VCA-IGG ELISA (June 22, 1992)
  • K911571 — EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (June 10, 1991)
  • K910872 — EBV IGG ELISA TEST (April 12, 1991)

FDA data resources