Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit

• • Terminated Z-0755-2007 FDA Unclassified (pre-2012) ·initiated 14 Mar 2007

  A lot to lot inconsistency was noted on kits of ETI EBNA G.

510(k) Number

K946158 ↗

FDA Product Code

LLM

Device Class

Class I

Regulation

21 CFR Part 866.3235

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530

  Class II

  FDA 510(k) K960434 Active Cleared 17 Oct 1996

• Incstar Epstein-Barr Viral Capsid Antigen (Vca) Lgm Elisa Kit

  Class I

  FDA 510(k) K946157 Active Cleared 7 Jun 1995

• Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit

  Class I

  FDA 510(k) K946159 Active Cleared 7 Jun 1995

• Incstar's Birch Allergen Disc

  Class II

  FDA 510(k) K880168 Active Cleared 11 May 1988

• Incstar's Dandelion Allergen Disc

  Class II

  FDA 510(k) K880187 Active Cleared 21 Apr 1988

• BETA2 M-Trac by Enzyme Bead-Based Immunoassay Eia

  Class II

  FDA 510(k) K895496 Active Cleared 17 Oct 1989

See all devices from Incstar Corp. →