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DRUCKER 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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Joshua Crouse
EUDAMED SRN
US-MF-000031517
FDA FEI Number
—
DUNS Number
022156957

Catalogue (543)

Page 1 of 11
DeviceModel / ReferenceRegistriesClassStatus
DASH Apex 6 Centrifuge, LabCorp 00-076-026-000
FDA UDI
Class IActive
642B Centrifuge, Boston Heart 00-016-083-000
FDA UDI
Class IActive
755VES Centrifuge, VWR 00-045-037-000
FDA UDI
Class IActive
642E Centrifuge, Bio Reference 00-018-001-001
FDA UDI
Class IActive
Horizon 6 Flex Centrifuge, Fisher 00-376-018-000
FDA UDI
Class IActive
Horizon 24-AV Centrifuge 00-284-129-001
FDA UDI
Class IActive
755V Centrifuge, Drucker 00-041-009-000
FDA UDI
Class IActive
Horizon 6 Flex FA Centrifuge, Medline 00-376-215-001
FDA UDI
Class IActive
DASH Flex 12 Centrifuge, UC Health, 2 Speed 00-183-178-000
FDA UDI
Class IActive
DASH Flex 12 Centrifuge, LabCorp 00-183-026-000
FDA UDI
Class IActive
Horizon 6 Flex Centrifuge, DoWell Dental 00-376-257-000
FDA UDI
Class IActive
QBC Diagnostics 424305
FDA UDI
Class IIActive
DASH Apex 12, Drucker, International 00-083-009-001
FDA UDI
Class IActive
DASH Apex 6 Centrifuge, Cardinal CA076104
FDA UDI
Class IActive
614B Centrifuge, Fisher Scientific 00-004-018-000
FDA UDI
Class IActive
642M Centrifuge, BioReach Labs 00-077-249-000
FDA UDI
Class IActive
614B Centrifuge, Medshift 00-004-138-000
FDA UDI
Class IActive
QBC Diagnostics 427760
FDA UDI
Class IIActive
642E Centrifuge, Simple Laboratories 00-018-285-000
FDA UDI
Class IActive
755-24 Centrifuge, Ascend 00-040-051-000
FDA UDI
Class IActive
642E Centrifuge, Cardinal CA018104
FDA UDI
Class IActive
DASH Flex 12 Centrifuge, Drucker, Brazil 00-183-009-001
FDA UDI
Class IActive
DASH Coag Centrifuge, Medline, Tall Rotor 00-676-215-001
FDA UDI
Class IActive
DASH Apex 24, Drucker 00-084-009-005
FDA UDI
Class IActive
QBC Diagnostics 42857609
FDA UDI
Class IIActive
642VES Centrifuge, Glofinn 00-024-102-000
FDA UDI
Class IActive
642M Centrifuge, VWR 00-077-037-000
FDA UDI
Class IActive
642VFD Plus Centrifuge, Bellus 00-027-141-000
FDA UDI
Class IActive
DASH Apex 12 Centrifuge, Drucker, Brazil 00-083-009-004
FDA UDI
Class IActive
QBC Diagnostics 424450
FDA UDI
Class IIActive
Horizon 6 Centrifuge, Sarstedt (US) 00-476-034-000
FDA UDI
Class IActive
755VES Centrifuge, Breeder's Choice 00-045-082-000
FDA UDI
Class IActive
Horizon 24 Flex-AH, Full Kit 00-389-129-000K
FDA UDI
Class IActive
DASH Flex 6 Centrifuge, Medline 00-176-215-000
FDA UDI
Class IActive
Boost 4+ Flex Centrifuge, Drucker, Platform Mount 00-389-009-001
FDA UDI
Class IActive
SERO 12 Centrifuge, Medline, Pop-Lid 00-483-215-001
FDA UDI
Class IActive
Horizon 24-AH Centrifuge 00-284-129-000
FDA UDI
Class IActive
SERO 12, Fisher 00-483-018-000
FDA UDI
Class IActive
642VES Centrifuge, Estar Medical 00-024-111-000
FDA UDI
Class IActive
DASH Micro Centrifuge, Nuo 00-050-255-000
FDA UDI
Class IUnknown
SERO 12 Centrifuge, LabCorp, Pop Up Lid 00-483-026-001
FDA UDI
Class IActive
Horizon 12 Centrifuge, Woodley 00-283-038-000
FDA UDI
Class IActive
755V-24 Centrifuge, Drucker 00-043-009-000
FDA UDI
Class IActive
Horizon 6FA Centrifuge, Suneva 00-276-225-000
FDA UDI
Class IActive
642E Centrifuge, Drucker 00-018-009-001
FDA UDI
Class IActive
DASH Coag Centrifuge, VWR, Tall Rotor 00-676-037-001
FDA UDI
Class IActive
Horizon 12, Drucker 00-283-009-000
FDA UDI
Class IActive
TrueBond Set 3 (Horizon 6 FA (DC)) Centrifuge, Drucker 00-276-009-007
FDA UDI
Class IActive
Horizon 6FA Centrifuge, Top Shelf Ortho 00-276-281-000
FDA UDI
Class IActive
642VFD Plus Centrifuge, Selphyl US/CAN 00-027-055-001
FDA UDI
Class IActive

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