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Sign in to claim this brandDRUCKER DIAGNOSTICS
United States·US-MF-000031517
Last updated May 23, 2026
What DRUCKER DIAGNOSTICS makes
The company manufactures general-purpose centrifuges for in vitro diagnostics (IVD), including models designed for full blood count analysis and cell counting. It also produces capillary blood collection tubes without additives, rapid diagnostic kits for detecting multiple Plasmodium species via antigen and nucleic acid techniques, and microscope light sources paired with biological stain kits for IVD use. Additional offerings include full blood count controls and rapid immunochromatographic tests (ICT) for clinical Plasmodium detection.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable domestic and international regulatory standards for in vitro diagnostics and medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Drucker Diagnostics manufacture?
Drucker Diagnostics specializes in in vitro diagnostics (IVD) devices, primarily general-purpose centrifuges used for tasks like full blood count analysis and cell counting. Their portfolio also includes capillary blood collection tubes without additives, rapid diagnostic kits for detecting multiple Plasmodium species (both antigen-based and nucleic acid-based), microscope light sources paired with biological stain kits, and full blood count controls. These devices are designed for clinical, laboratory, and point-of-care settings.
Where is Drucker Diagnostics based, and what regulatory regions do they serve?
Drucker Diagnostics is headquartered in the United States. While the company’s exact regulatory reach isn’t specified, its devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with U.S. regulatory requirements for medical devices. Their products are likely intended for global markets, adhering to applicable domestic and international standards for IVDs and medical devices.
Which regulatory registries or databases list Drucker Diagnostics’ devices?
Drucker Diagnostics’ devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for sale in the U.S., ensuring traceability and compliance with regulatory requirements. The inclusion in this database reflects the company’s adherence to FDA standards for device identification and reporting.
How are Drucker Diagnostics’ devices classified under regulatory frameworks?
Drucker Diagnostics’ devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential health impact, and the level of regulatory oversight required, as determined by regulatory bodies like the FDA.
What kinds of in vitro diagnostic (IVD) tests or procedures do Drucker Diagnostics’ devices support?
Drucker Diagnostics’ devices support a range of IVD procedures, including centrifugation for blood analysis (such as full blood counts and cell counting), rapid diagnostic testing for Plasmodium species (malaria detection via antigen or nucleic acid techniques), and microscopy applications enabled by their biological stain kits and microscope light sources. These devices are designed to assist in clinical diagnostics, ensuring accurate and efficient testing for conditions like infectious diseases or hematological disorders.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 200, Shady Lane, Philipsburg, United States
- Website
- www.druckerdiagnostics.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Joshua Crouse
- EUDAMED SRN
- US-MF-000031517
- FDA FEI Number
- —
- DUNS Number
- 022156957
Catalogue (543)
Page 5 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Horizon 6 Centrifuge, Clinical Labs of Hawaii | 00-276-115-000 | FDA UDI | Class I | Active |
| QBC Diagnostics | 42900209C | FDA UDI | Class II | Active |
| Horizon 24 Flex Centrifuge, Royal Biologics | 00-384-005-000 | FDA UDI | Class I | Active |
| DASH Coag Centrifuge, Labforce, Tall Rotor | 00-676-210-001 | FDA UDI | Class I | Active |
| QBC Diagnostics | 427400 | FDA UDI | Class II | Active |
| DASH Flex 24 Centrifuge, Restek | 00-184-047-000 | FDA UDI | Class I | Active |
| 755-12 Centrifuge, Davita | 00-039-008-000 | FDA UDI | Class I | Active |
| Horizon 6 Flex FA, Drucker | 00-376-009-001 | FDA UDI | Class I | Active |
| 642B Centrifuge, VWR | 00-016-037-000 | FDA UDI | Class I | Active |
| 642VFD Plus , RegenLab, Euro | 00-027-088-002 | FDA UDI | Class I | Active |
| DASH Apex 4 Centrifuge, Drucker | 00-053-009-000 | FDA UDI | Class I | Active |
| 653V Centrifuge, Bio Reference | 00-032-001-000 | FDA UDI | Class I | Active |
| QBC Diagnostics | 429578 | FDA UDI | Class II | Active |
| DASH Apex 4 Centrifuge, Medline | 00-053-215-000 | FDA UDI | Class I | Active |
| Horizon 6 Centrifuge, Ultrapure | 00-276-246-000 | FDA UDI | Class I | Active |
| 755VES Centrifuge, Bellus | 00-045-108-000 | FDA UDI | Class I | Active |
| QBC Diagnostics | 429609 | FDA UDI | Class II | Active |
| DASH Flex 6 Centrifuge, VWR | 00-176-037-000 | FDA UDI | Class I | Active |
| DASH Flex 12 Centrifuge, VWR | 00-183-037-000 | FDA UDI | Class I | Active |
| 642E Centrifuge, Westpac Labs | 00-018-192-000 | FDA UDI | Class I | Active |
| LC 24 (Horizon 24 Flex) Centrifuge, Sarstedt (Brazil) | 00-384-034-001 | FDA UDI | Class I | Active |
| 755VES Centrifuge, Restek | 00-045-047-000 | FDA UDI | Class I | Active |
| 853VES Centrifuge, VWR, Standard | 00-054-037-000 | FDA UDI | Class I | Active |
| Horizon 12 Centrifuge, Pamark | 00-283-174-000 | FDA UDI | Class I | Active |
| 642E Centrifuge, Southwest Labs | 00-018-201-000 | FDA UDI | Class I | Active |
| Horizon 12 Flex Centrifuge, Pamark | 00-383-174-000 | FDA UDI | Class I | Active |
| DASH Apex 4 Centrifuge, Cardinal | CA053104 | FDA UDI | Class I | Active |
| 755VES Centrifuge, Vertical Spine | 00-045-005-000 | FDA UDI | Class I | Active |
| Horizon 6 Flex FA, NextMDLink | 00-376-282-000 | FDA UDI | Class I | Active |
| 642VFD Plus , RegenLab, Swiss | 00-027-088-003 | FDA UDI | Class I | Active |
| 642E Centrifuge, Conexus | 00-018-137-000 | FDA UDI | Class I | Active |
| Horizon 24 Flex Centrifuge, VWR | 00-384-037-000 | FDA UDI | Class I | Active |
| 755VES Centrifuge, 230V, Woodley | 00-046-038-000 | FDA UDI | Class I | Active |
| DASH Flex 12 Centrifuge, Medline | 00-183-215-000 | FDA UDI | Class I | Active |
| 853VES Centrifuge, 230V, Drucker, Performance Plus | 00-055-009-001 | FDA UDI | Class I | Active |
| 642E Centrifuge, American Esoteric | 00-018-112-000 | FDA UDI | Class I | Active |
| Horizon 24 Flex Centrifuge, Boekel | 00-384-260-000 | FDA UDI | Class I | Active |
| 642E Centrifuge, Accu Reference | 00-018-241-000 | FDA UDI | Class I | Active |
| 642E Centrifuge, Accurate Diagnostics Lab | 00-018-144-000 | FDA UDI | Class I | Active |
| Horizon 6 Flex FA Centrifuge, Tulip Medical | 00-376-253-000 | FDA UDI | Class I | Active |
| 755VES Centrifuge, Drucker (MTF) | 00-045-005-002 | FDA UDI | Class I | Active |
| Horizon 6 FA DC Centrifuge, RegenLab, Swiss | 00-276-088-002 | FDA UDI | Class I | Unknown |
| SERO 12 Centrifuge, Boekel, Pop Up Lid | 00-483-260-001 | FDA UDI | Class I | Active |
| Horizon 24 Centrifuge, Greiner Bio-One | 00-284-024-000 | FDA UDI | Class I | Active |
| QBC Diagnostics | 424346 | FDA UDI | Class II | Active |
| Horizon 12 Centrifuge, MarketLab | 00-283-148-000 | FDA UDI | Class I | Active |
| Horizon 6 Flex Centrifuge, VWR | 00-376-037-000 | FDA UDI | Class I | Active |
| 755VES 230V Centrifuge, Biomet | 00-046-002-000 | FDA UDI | Class I | Active |
| DASH Coag, Drucker | 00-676-009-000 | FDA UDI | Class I | Unknown |
| 642E Centrifuge, Gulf Stream | 00-018-110-000 | FDA UDI | Class I | Active |
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