Incstar Rubella Igg Elisa Assay

• • Terminated Z-0922-2010 FDA Unclassified (pre-2012) ·initiated 16 Dec 2009

  DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.

510(k) Number

K960367 ↗

FDA Product Code

LFX

Device Class

Class II

Regulation

21 CFR Part 866.3510

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

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