Gamma Dab (125I) AFP RIA Kit

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

PMA Number

P790032 ↗

FDA Product Code

LOK

Device Class

Class III

Advisory Committee

Immunology

FDA Decision

APWD Approval withdrawn

• 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. →