MedtechSourcebook

Cytology Kit (OKY) contract manufacturers

5 US facilities list FDA product code OKY as a contract manufacturer (1) or contract sterilizer (4).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Cytology Kit
Product code
OKY (FDA product classification database)
Device class
Class II
Regulation
21 CFR 884.4530
Classification panel
Obstetrics and gynecology

Where they are

Texas 3 · Connecticut 1 · North Carolina 1

All 5 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
AERO-MED LLC3006191977Contract manufacturerGeneral hospital; Pathology; General and plastic surgery +4 moreEast Hartford, CTNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations Inc3009888344Contract sterilizerGastroenterology and urology; General and plastic surgery; General hospital +13 moreEl Paso, TXNot verifiedOct 21, 2026
Sterigenics U.S., LLC1061124Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreCharlotte, NCNot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026

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