Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3

• • Ongoing Z-1421-2022 FDA Class II ·initiated 13 Jun 2022

  There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

510(k) Number

K092963 ↗

FDA Product Code

MQL

FDA applicant

Genx Intl., Inc.

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• <genx> Single Lumen Sideport Needle

  Class II

  FDA 510(k) K991264 Active Cleared 9 Sep 1999

• Genxcatheter

  Class II

  FDA 510(k) K963031 Active Cleared 21 Oct 1996

• Global by <genx> Blastocyst Media

  Class II

  FDA 510(k) K010183 Active Cleared 2 May 2001

• Allgrad Wash (Herpes Buffered Washing Medium)

  Class II

  FDA 510(k) K023033 Active Cleared 26 Nov 2002

• Htf Plus - Htf with Non-Essential Amino Acids

  Class II

  FDA 510(k) K022334 Active Cleared 28 Aug 2002

• Genx Microtools

  Class II

  FDA 510(k) K993884 Active Cleared 14 Feb 2000

See all devices from <Genx> Intl., Inc. →