MedtechSourcebook

Counter, Differential Cell (GKZ) contract manufacturers

8 US facilities list FDA product code GKZ as a contract manufacturer (7) or contract sterilizer (1).

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

FDA device name
Counter, Differential Cell
Product code
GKZ (FDA product classification database)
Device class
Class II
Regulation
21 CFR 864.5220
Classification panel
Hematology

Where they are

California 2 · Illinois 2 · Florida 1 · Nebraska 1 · Puerto Rico 1 · Virginia 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ANTIBODIES INCORPORATED2914537Contract manufacturerHematology; PathologyDavis, CANot verifiedOct 21, 2026
BECKMAN COULTER, INC.1017835Contract manufacturerHematology; PathologyHialeah, FLNot verifiedOct 21, 2026
Becton Dickinson Caribe, LTD3008352382Contract manufacturerHematology; Pathology; ImmunologyCayey, PRNot verifiedOct 21, 2026
Fisher Diagnostics1181121Contract manufacturerClinical chemistry; Immunology; Hematology +4 moreMiddletown, VANot verifiedOct 21, 2026
Isomedix Operations Inc.2032112Contract sterilizerCardiovascular; General hospital; Gastroenterology and urology +13 moreSan Diego, CANot verifiedOct 21, 2026
STRECK LLC1950302Contract manufacturerHematologyLa Vista, NENot verifiedOct 21, 2026
Sysmex America, Inc.3009495621Contract manufacturerClinical chemistry; HematologyBuffalo Grove, ILNot verifiedOct 21, 2026
Sysmex America, Inc. - Vernon Hills3020704087Contract manufacturerClinical chemistry; HematologyVernon Hills, ILNot verifiedOct 21, 2026

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