Clinical toxicology device contract manufacturers
28 US facilities list clinical toxicology devices with FDA as a contract manufacturer (20) or contract sterilizer (8), across 73 FDA product codes in the Clinical toxicology classification panel.
FDA-registered (openFDA, export of Oct 21, 2026)
Most-listed clinical toxicology device types
| Product code | Device (FDA name) | Class | Facilities |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Class II | 7 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | 6 |
| DIS | Enzyme Immunoassay, Barbiturate | Class II | 6 |
| DJG | Enzyme Immunoassay, Opiates | Class II | 6 |
| DJR | Enzyme Immunoassay, Methadone | Class II | 6 |
| DKZ | Enzyme Immunoassay, Amphetamine | Class II | 6 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unclassified | 6 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Class II | 6 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Class II | 5 |
Where they are
Top states by registered address.
| State | Facilities |
|---|---|
| California | 8 |
| Texas | 7 |
| Florida | 2 |
| Indiana | 2 |
| Massachusetts | 2 |
| North Carolina | 2 |
| New York | 2 |
| Delaware | 1 |
| Pennsylvania | 1 |
| Virginia | 1 |
Device classes listed
Facilities listing at least one clinical toxicology device of each FDA class.
| Class | Facilities |
|---|---|
| Class II | 23 |
| Unclassified | 10 |
| Class I | 7 |
All 28 facilities
| Company | FDA registration | Establishment type | Clinical toxicology devices listed | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ADVIN BIOTECH, INC. | 3010934853 | Contract manufacturer | Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Opiates +10 more | San Diego, CA | Not verified | Oct 21, 2026 |
| ALCOPATROL INC. | 3030453686 | Contract manufacturer | Devices, Breath Trapping, Alcohol | Houston, TX | Not verified | Oct 21, 2026 |
| ALFA SCIENTIFIC DESIGNS, INC. | 2060833 | Contract manufacturer | Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate +26 more | Poway, CA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2050010 | Contract manufacturer | Calibrators, Drug Specific; Enzyme Immunoassay, Cocaine And Cocaine Metabolites +28 more | Carlsbad, CA | Not verified | Oct 21, 2026 |
| BIONOSTICS, INC. | 1220649 | Contract manufacturer | Drug Mixture Control Materials | Devens, MA | Not verified | Oct 21, 2026 |
| CHEMATICS, INC. | 1825396 | Contract manufacturer | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | North Webster, IN | Not verified | Oct 21, 2026 |
| CURRIER PLASTICS | 1319436 | Contract manufacturer | Enzyme Immunoassay, Phenobarbital | Auburn, NY | Not verified | Oct 21, 2026 |
| Chemtron Biotech, Inc. | 3008852306 | Contract manufacturer | Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate +20 more | San Diego, CA | Not verified | Oct 21, 2026 |
| EKF Life Sciences | 3017101757 | Contract manufacturer | Colorimetry, Salicylate; Colorimetry, Acetaminophen | South Bend, IN | Not verified | Oct 21, 2026 |
| EXPRESS MANUFACTURING, INC | 2087572 | Contract manufacturer | Devices, Breath Trapping, Alcohol | Santa Ana, CA | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital +5 more | Middletown, VA | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 1643621 | Contract manufacturer | Calibrators, Drug Specific; Sirolimus Test System | Seguin, TX | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 2521625 | Contract manufacturer | Calibrators, Drug Specific; Sirolimus Test System | Malvern, PA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | Blood Alcohol Kit (Excludes Hiv Testing) | El Paso, TX | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Fluorescent Immunoassay Gentamicin | Northborough, MA | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Blood Alcohol Kit (Excludes Hiv Testing) | El Paso, TX | Not verified | Oct 21, 2026 |
| MLIFE DIAGNOSTICS LLC | 3017060097 | Contract manufacturer | Test, Amphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter +9 more | Marshall, TX | Not verified | Oct 21, 2026 |
| Microgenics Corporation | 3010939897 | Contract manufacturer | Calibrators, Drug Specific; Enzyme Immunoassay, Cocaine And Cocaine Metabolites +26 more | Fremont, CA | Not verified | Oct 21, 2026 |
| SIEMENS HEALTHCARE DIAGNOSTICS INC. | 2517506 | Contract manufacturer | Calibrators, Drug Specific; Enzyme Immunoassay, Barbiturate +7 more | Newark, DE | Not verified | Oct 21, 2026 |
| STANBIO LABORATORY | 1616487 | Contract manufacturer | Colorimetry, Salicylate; Colorimetry, Acetaminophen | Boerne, TX | Not verified | Oct 21, 2026 |
| STERIPACK USA (LIMITED) LLC | 3009656988 | Contract manufacturer | Strip, Test Isoniazid | Lakeland, FL | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 1054811 | Contract sterilizer | Strip, Test Isoniazid | Mulberry, FL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | Blood Alcohol Kit (Excludes Hiv Testing) | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | Calibrators, Drug Specific; Strip, Test Isoniazid | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1058584 | Contract sterilizer | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | Blood Alcohol Kit (Excludes Hiv Testing) | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| TESSY PLASTICS CORP. | 1317202 | Contract manufacturer | Radioimmunoassay, Vancomycin | Elbridge, NY | Not verified | Oct 21, 2026 |
| W.H.P.M., INC. | 2087033 | Contract manufacturer | Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate +28 more | Irwindale, CA | Not verified | Oct 21, 2026 |