MedtechSourcebook

General Purpose Reagent (PPM) contract manufacturers

25 US facilities list FDA product code PPM as a contract manufacturer (25) or contract sterilizer (1).

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

FDA device name
General Purpose Reagent
Product code
PPM (FDA product classification database)
Device class
Class I
Regulation
21 CFR 864.4010
Classification panel
Pathology

Where they are

California 7 · Maryland 3 · New Jersey 2 · Florida 1 · Illinois 1 · Indiana 1 · Kentucky 1 · Michigan 1 · Missouri 1 · North Carolina 1 · Ohio 1 · Pennsylvania 1 and 4 more states

All 25 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Advanced Cell Diagnostics, Inc.3009161685Contract manufacturerPathologyNewark, CANot verifiedOct 21, 2026
Agilent Technologies, Inc.2022180Contract manufacturerPathologyCarpinteria, CANot verifiedOct 21, 2026
AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI1177732Contract manufacturerPathologyGaithersburg, MDNot verifiedOct 21, 2026
ANTIBODIES INCORPORATED2914537Contract manufacturerHematology; PathologyDavis, CANot verifiedOct 21, 2026
AZER SCIENTIFIC, INC.3009963993Contract manufacturerHematology; Pathology; MicrobiologyMorgantown, PANot verifiedOct 21, 2026
BAEBIES INC.3011240982Contract manufacturerClinical chemistry; PathologyDurham, NCNot verifiedOct 21, 2026
BECKMAN COULTER, INC.1017835Contract manufacturerHematology; PathologyHialeah, FLNot verifiedOct 21, 2026
BECKMAN COULTER, INC.2050010Contract manufacturerClinical chemistry; Clinical toxicology; Immunology +3 moreCarlsbad, CANot verifiedOct 21, 2026
Beckman Coulter, Inc.3008629785Contract manufacturerHematology; Pathology; Clinical chemistryHebron, KYNot verifiedOct 21, 2026
Becton Dickinson Caribe, LTD3008352382Contract manufacturerHematology; Pathology; ImmunologyCayey, PRNot verifiedOct 21, 2026
CALBIOTECH, INC.2090110Contract manufacturerMicrobiology; Immunology; PathologyEl Cajon, CANot verifiedOct 21, 2026
CELL MARQUE CORP.1649339Contract manufacturerPathology; HematologyRocklin, CANot verifiedOct 21, 2026
DSRV, INC.3004737529Contract manufacturerHematology; PathologyMount Olive, NJNot verifiedOct 21, 2026
ELITechGroup Inc1717966Contract manufacturerClinical chemistry; PathologyLogan, UTNot verifiedOct 21, 2026
Ethos Biosciences, INC.2247035Contract manufacturerHematology; Pathology; MicrobiologyLogan Township, NJNot verifiedOct 21, 2026
Fisher Diagnostics1181121Contract manufacturerClinical chemistry; Immunology; Hematology +4 moreMiddletown, VANot verifiedOct 21, 2026
Infrared Laboratory Systems dba SYNERMED3003593973Contract manufacturerPathologyWestfield, INNot verifiedOct 21, 2026
Leica Biosystems Richmond, Inc.1419341Contract manufacturerPathology; Clinical chemistryRichmond, ILNot verifiedOct 21, 2026
LONZA WALKERSVILLE, INC.1114298Contract manufacturerHematology; Pathology; MicrobiologyWalkersville, MDNot verifiedOct 21, 2026
ML LifeSciences3006793669Contract manufacturer and sterilizerPathologyIrvine, CANot verifiedOct 21, 2026
Promega Corporation2134567Contract manufacturerClinical chemistry; PathologyMadison, WINot verifiedOct 21, 2026
QIAGEN1122376Contract manufacturerPathologyGermantown, MDNot verifiedOct 21, 2026
RICHARD-ALLAN SCIENTIFIC LLC1831638Contract manufacturerPathology; HematologyKalamazoo, MINot verifiedOct 21, 2026
SIGMA-ALDRICH MANUFACTURING, LLC1938173Contract manufacturerPathology; Hematology; ImmunologySt. Louis, MONot verifiedOct 21, 2026
VWR CHEMICALS, LLC1550222Contract manufacturerClinical chemistry; Microbiology; Pathology +3 moreSolon, OHNot verifiedOct 21, 2026

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