MedtechSourcebook

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) contract manufacturers

22 US facilities list FDA product code JJX as a contract manufacturer (20) or contract sterilizer (2).

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

FDA device name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code
JJX (FDA product classification database)
Device class
Class I
Regulation
21 CFR 862.1660
Classification panel
Clinical chemistry

Where they are

California 8 · Massachusetts 4 · Georgia 1 · Maryland 1 · Minnesota 1 · Pennsylvania 1 · South Dakota 1 · Texas 1 · Utah 1 · Virginia 1 · Washington 1 · Wisconsin 1

All 22 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
AALTO SCIENTIFIC LTD.3011325031Contract manufacturerClinical chemistry; Hematology; MicrobiologyEatonton, GANot verifiedOct 21, 2026
ACON LABORATORIES, INC.2531491Contract manufacturerClinical chemistrySan Diego, CANot verifiedOct 21, 2026
BECKMAN COULTER, INC.2050010Contract manufacturerClinical chemistry; Clinical toxicology; Immunology +3 moreCarlsbad, CANot verifiedOct 21, 2026
BIO-RAD LABORATORIES, INC.3032705Contract manufacturerMicrobiology; Immunology; Clinical chemistryWoodinville, WANot verifiedOct 21, 2026
BIONOSTICS, INC.1220649Contract manufacturerClinical chemistry; Hematology; Clinical toxicologyDevens, MANot verifiedOct 21, 2026
CLINIQA CORPORATION2085064Contract manufacturerClinical chemistry; Hematology; ImmunologySan Marcos, CANot verifiedOct 21, 2026
CONE BIOPRODUCTS OF SEGUIN LLC3004152597Contract manufacturerClinical chemistrySeguin, TXNot verifiedOct 21, 2026
DIASORIN INC.2182595Contract manufacturerClinical chemistry; Immunology; MicrobiologyStillwater, MNNot verifiedOct 21, 2026
Fisher Diagnostics1181121Contract manufacturerClinical chemistry; Immunology; Hematology +4 moreMiddletown, VANot verifiedOct 21, 2026
Fujirebio Diagnostics, Inc.2521625Contract manufacturerClinical chemistry; Immunology; Clinical toxicology +2 moreMalvern, PANot verifiedOct 21, 2026
GL DIABETES CORPORATION3009129531Contract manufacturerClinical chemistrySan Diego, CANot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1720929Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +11 moreSandy, UTNot verifiedOct 21, 2026
Isomedix Operations, Inc2032098Contract sterilizerOrthopedic; General and plastic surgery; General hospital +12 moreOntario, CANot verifiedOct 21, 2026
MAXIM BIOMEDICAL INC.1122236Contract manufacturerClinical chemistry; MicrobiologyRockville, MDNot verifiedOct 21, 2026
Microgenics Corporation3010939897Contract manufacturerClinical toxicology; Clinical chemistry; Hematology +1 moreFremont, CANot verifiedOct 21, 2026
NOVA BIOMEDICAL CORPORATION1219029Contract manufacturerClinical chemistry; HematologyWaltham, MANot verifiedOct 21, 2026
Nova Biomedical Corporation3011979858Contract manufacturerClinical chemistryBillerica, MANot verifiedOct 21, 2026
NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS3004193489Contract manufacturerClinical chemistryBillerica, MANot verifiedOct 21, 2026
OSANG LLC3020885868Contract manufacturerClinical chemistryS Pasadena, CANot verifiedOct 21, 2026
QUANTIMETRIX CORP.2020715Contract manufacturerClinical chemistry; HematologyRedondo Beach, CANot verifiedOct 21, 2026
RR DONNELLEY-SUPPLY CHAIN SOLUTIONS3006371704Contract manufacturerClinical chemistry; Cardiovascular; AnesthesiologyPlover, WINot verifiedOct 21, 2026
Spartronics Watertown LLC2133772Contract manufacturerNeurology; Radiology; Clinical chemistry +8 moreWatertown, SDNot verifiedOct 21, 2026

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