Cmv Early Antigen Test

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K942171 ↗

FDA Product Code

GQI

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Chlamydia Trachomatis Antigen Test

  Class I

  FDA 510(k) K941714 Active Cleared 18 Jul 1994

• Rsv Antigen Test

  Class I

  FDA 510(k) K942173 Active Cleared 30 Jun 1994

• Influenza a Antigen Test

  Class I

  FDA 510(k) K942172 Active Cleared 6 Jul 1994

• Influenza B Anitgen Test

  Class I

  FDA 510(k) K942174 Active Cleared 30 Jun 1994

• Primary Monkey Kidney Cell Culture

  Class I

  FDA 510(k) K943884 Active Cleared 28 Nov 1994

• Mccoy Culture Cell

  Class I

  FDA 510(k) K933924 Active Cleared 29 Mar 1994

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