Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696

• • Terminated Z-2285-2012 FDA Class III ·initiated 2 Aug 2012

  Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.

510(k) Number

K020758 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Varelisa Cardiolipin Iga Antibodies, Models 15748 & 15796

  Class II

  FDA 510(k) K020757 Active Cleared 2 May 2002

• Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996

  Class II

  FDA 510(k) K040450 Active Cleared 11 May 2004

• Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096

  Class II

  FDA 510(k) K040452 Active Cleared 11 May 2004

• Varelisa Ssdna Antibodies, Model 14896

  Class II

  FDA 510(k) K040811 Active Cleared 13 May 2004

• Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796

  Class II

  FDA 510(k) K040449 Active Cleared 11 May 2004

• Varelisa Histone Antibodies, Model 16496

  Class II

  FDA 510(k) K040810 Active Cleared 14 May 2004

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