MedtechSourcebook

Urine Collection Kit (Excludes Hiv Testing) (OIE) contract manufacturers

7 US facilities list FDA product code OIE as a contract manufacturer (3) or contract sterilizer (4).

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

FDA device name
Urine Collection Kit (Excludes Hiv Testing)
Product code
OIE (FDA product classification database)
Device class
Class I
Regulation
21 CFR 864.3250
Classification panel
Pathology

Where they are

Texas 3 · North Carolina 2 · California 1 · Georgia 1

All 7 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
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
MEDICAL ACTION INDUSTRIES, INC. 3061030451Contract manufacturerGeneral and plastic surgery; General hospital; Anesthesiology +8 moreArden, NCNot 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
The Dot Printer Inc.3011057574Contract manufacturerPathology; Microbiology; Clinical chemistryIrvine, CANot verifiedOct 21, 2026
Therapak, LLC3044182936Contract manufacturerPathologyOakwood, GANot verifiedOct 21, 2026

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