Varicella Zoster Igg Clin-Elisa Test Kit

• • Terminated Z-0572-05 FDA Unclassified (pre-2012) ·initiated 10 Sep 2003

  Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.

510(k) Number

K900688 ↗

FDA Product Code

LFY

Device Class

Class II

Regulation

21 CFR Part 866.3900

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Epstein-Barr Viral Capsid Antigen Igg #4590

  Class I

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• Epstein-Barr Virus (Ebna-1) Igg Cata. #4550

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• Immunop. Antismooth Muscle Antibody Kit

  Class II

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• Igm Cmv Clin-Elisa(Tm) Test System Number: 5530

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• Rapid Plasma Reagin Card Test

  Class II

  FDA 510(k) K842541 Active Cleared 26 Jul 1984

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