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Sign in to claim this brandDiagnostic Automation, Inc.
US
Last updated May 24, 2026
What Diagnostic Automation, Inc. makes
Diagnostic Automation, Inc. manufactures a range of in vitro diagnostic kits, including enzyme immunoassays for thyroid stimulating hormone, total thyroxine, and therapeutic drug monitoring for digoxin. The company also produces rapid colorimetric clinical urine analyte tests and various antibody detection kits for pathogens such as Borrelia burgdorferi, Rubella virus, Herpes simplex virus, and Measles virus. These products are marketed under brand names including QMedix, AccuDiag, and InstaTest.
The company is based in the United States and maintains a portfolio consisting of Class I and Class II medical devices. These products are listed within the FDA UDI database for regulatory tracking and identification purposes.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
Where is Diagnostic Automation, Inc. based and what do they manufacture?
Diagnostic Automation, Inc. is a company based in the United States. They specialize in the manufacturing of various in vitro diagnostic kits. Their product range includes enzyme immunoassays for thyroid stimulating hormone, total thyroxine, and digoxin therapeutic drug monitoring, as well as rapid colorimetric clinical urine analyte tests and antibody detection kits for pathogens like Borrelia burgdorferi, Rubella, Herpes simplex, and Measles.
How are the medical devices from Diagnostic Automation, Inc. classified?
The medical device portfolio offered by Diagnostic Automation, Inc. consists of both Class I and Class II medical devices. This classification system is used to categorize devices based on the level of regulatory control necessary to ensure their safety and effectiveness for their intended use.
Where can I find regulatory information regarding the devices produced by this company?
The devices manufactured by Diagnostic Automation, Inc. are listed within the FDA UDI database. This database serves as a regulatory registry for tracking and identification purposes, ensuring that each device can be properly monitored throughout its lifecycle.
What are the brand names associated with the products from Diagnostic Automation, Inc.?
Diagnostic Automation, Inc. markets its range of in vitro diagnostic kits and clinical tests under several specific brand names. These include QMedix, AccuDiag, and InstaTest. These brands cover the company's diverse offerings, which range from enzyme immunoassays to rapid colorimetric urine analyte tests.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rapidtest.com
- —
- —
- [email protected]
- Phone
- 8185913030
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 878252071
Catalogue (77)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| QMedix™ | DACD3146-15 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8207-35 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD1412-1 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8209-35 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD 8319-35 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD 1444-2 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8043-2 | FDA UDI | Class I | Active |
| QMedix™ | DACD1101-1 | FDA UDI | Class II | Active |
| AccuDiag™ | DACD 3126-15 | EUDAMEDFDA UDI | Class II | Active |
| AccuDiag™ | DACD 1409-1 | FDA UDI | Class I | Active |
| InstaTest | DACDURS-1P (100) | FDA UDI | Class I | Active |
| QMedix™ | DACD3122-15 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8208-35 | FDA UDI | Class II | Active |
| InstaTest | URS-2P (100) | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8212-35 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD2925-15 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD-1681-2 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD351-50 | FDA UDI | Class II | Active |
| OneStep | DACD 113029-1-19 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD 1201-2 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD3144-18 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD1669-15 | FDA UDI | Class II | Active |
| QMedix™ | DACD13010-1-19 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD1302-1 | FDA UDI | Class II | Active |
| Qmedix | DACD3144-18 | FDA UDI | Class II | Active |
| QMedix™ | DACD 320-100 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD1506-12 | FDA UDI | Class I | Active |
| InstaTest™ | DACD330-50 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD 1301-2 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD-351010 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD1427-2 | FDA UDI | Class II | Active |
| QMedix™ | DACD1408-1 | FDA UDI | Class I | Active |
| QMedix™ | DACD 351010 | FDA UDI | Class II | Active |
| QMedix™ | DACD1444-2 | FDA UDI | Class II | Active |
| AccuDiag™ | DACD 1202-2 | FDA UDI | Class II | Active |
| QMedix™ | DACD1423-55 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD2046-18 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD-2555-2 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD3123-16 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD3149-18 | FDA UDI | Class II | Active |
| AccuDiag™ | DACD320-100 | FDA UDI | Class II | Active |
| Diagnostic Automation | DAW50TS | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD2095-18 | FDA UDI | Class I | Active |
| AccuDiag ™ | DACD 8206-35 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD-2550-1 | FDA UDI | Class II | Active |
| QMedix™ | DACD3149-18 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD8119-35 | FDA UDI | Class II | Active |
| AccuDiag ™ | DACD 500100-500 | FDA UDI | Class II | Active |
| QMedix™ | DACD1301-1 | FDA UDI | Class II | Active |
| QMedix™ | DACD5102-2 | FDA UDI | Class II | Unknown |
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