MedtechSourcebook

Device, Specimen Collection (LIO) contract manufacturers

11 US facilities list FDA product code LIO as a contract manufacturer (6) or contract sterilizer (5).

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

FDA device name
Device, Specimen Collection
Product code
LIO (FDA product classification database)
Device class
Class I
Regulation
21 CFR 866.2900
Classification panel
Microbiology

Where they are

California 3 · Tennessee 2 · Massachusetts 1 · Maine 1 · Minnesota 1 · Nebraska 1 · Oregon 1 · Puerto Rico 1

All 11 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Cardinal Health1915484Contract manufacturerClinical chemistry; Microbiology; General and plastic surgeryNorfolk, NENot verifiedOct 21, 2026
COPAN DIAGNOSTICS, INC.2436875Contract manufacturerMicrobiologyMurrieta, CANot verifiedOct 21, 2026
COPAN Diagnostics, Inc.3017063217Contract manufacturerMicrobiologyCarlsbad, CANot verifiedOct 21, 2026
Copan Industries, Inc.3015441043Contract manufacturerMicrobiology; General hospitalAguadilla, PRNot verifiedOct 21, 2026
DeRoyal Industries, Inc.1054241Contract sterilizerGeneral and plastic surgery; General hospital; Gastroenterology and urology +14 moreNew Tazewell, TNNot verifiedOct 21, 2026
DEROYAL INDUSTRIES, INC.1055236Contract sterilizerGeneral and plastic surgery; General hospital; Gastroenterology and urology +14 moreNew Tazewell, TNNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1220477Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreNorthborough, MANot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
MML DIAGNOSTICS PACKAGING, INC.3018348Contract manufacturerMicrobiology; Cardiovascular; PathologyTroutdale, ORNot verifiedOct 21, 2026
PURITAN MEDICAL PRODUCTS COMPANY LLC1216735Contract manufacturerMicrobiology; General hospitalGuilford, MENot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026

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