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510(k) K871298

EBNA ACIF ASSAY KIT by Granbio, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Granbio, Inc.

  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K934774 — UNKNOWN (April 20, 1994)
  • K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (June 7, 1988)
  • K864347 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA (February 2, 1987)
  • K864604 — EBV VCA IGM ANTIBODY ASSAY KIT (February 2, 1987)

Other clearances for product code LLM

  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (April 29, 2005)
  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)