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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)

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DeviceModel / ReferenceRegistriesClassStatus
Horizon 6 Flex FA Centrifuge, Fisher 00-376-018-001
FDA UDI
Class IActive
SERO 12 Centrifuge, Cardinal CA483104
FDA UDI
Class IActive
642B Centrifuge, MarketLab 00-016-148-000
FDA UDI
Class IActive
DASH Coag Centrifuge, VWR 00-676-037-000
FDA UDI
Class IUnknown
DASH Coag Centrifuge, Boekel, Tall Rotor 00-676-260-001
FDA UDI
Class IActive
642B Centrifuge, Medline 00-016-215-000
FDA UDI
Class IActive
Boost 4+ Flex Centrifuge, Dr. PRP 00-389-102-002
FDA UDI
Class IUnknown
Horizon 24 Flex Centrifuge, Drucker, Brazil 00-384-009-001
FDA UDI
Class IActive
642E Centrifuge, Clinical Pathology 00-018-116-000
FDA UDI
Class IActive
853VES Centrifuge, Cytonics 00-054-077-000
FDA UDI
Class IActive
Horizon 24 Flex Centrifuge, Westpac 00-384-192-000
FDA UDI
Class IActive
DASH Coag Centrifuge, Medline 00-676-215-000
FDA UDI
Class IUnknown
DASH Apex 24 Centrifuge, Drucker, Brazil 00-084-009-006
FDA UDI
Class IActive
Horizon 6 FA (DC) Centrifuge, Drucker 00-276-009-006
FDA UDI
Class IActive
642E Centrifuge, Lux Diagnostics 00-018-279-000
FDA UDI
Class IActive
642E Centrifuge, Davita 00-018-008-001
FDA UDI
Class IActive
756 Centrifuge, Celling 00-063-043-000
FDA UDI
Class IActive
Horizon 12 Centrifuge, Greiner Bio-One 00-283-024-000
FDA UDI
Class IActive
642VFD Plus , RegenLab, US/Canada 00-027-088-001
FDA UDI
Class IActive
Horizon 6 Centrifuge, Axial Biologics 00-276-264-000
FDA UDI
Class IActive
642M Centrifuge, Drucker 00-077-009-000
FDA UDI
Class IActive
Horizon 6 Flex FA, Drucker Modified 00-376-009-004
FDA UDI
Class IActive
Horizon 24 Centrifuge, Woodley 00-284-038-000
FDA UDI
Class IActive
DASH Flex 24, Axial Biologics 00-184-264-000
FDA UDI
Class IActive
642M Centrifuge, Medline 00-077-215-000
FDA UDI
Class IActive
DASH Apex 6 Centrifuge, Antnor 00-076-283-000
FDA UDI
Class IActive
755V-24 Centrifuge, Falcon 00-043-081-000
FDA UDI
Class IActive
Horizon 24 Flex Centrifuge, Lapidot 00-384-214-000
FDA UDI
Class IActive
Horizon 6 Flex FA (DC) Centrifuge, Drucker Modified 00-376-009-008
FDA UDI
Class IActive
QBC Diagnostics 424340
FDA UDI
Class IIActive
Horizon 6 Flex Centrifuge, Royal Biologics 00-376-005-000
FDA UDI
Class IActive
653V Centrifuge, Garcia Lab 00-032-075-000
FDA UDI
Class IActive
642VFD Plus Centrifuge, Selphyl EUR 00-027-055-002
FDA UDI
Class IActive
DASH Apex 4 Centrifuge, Fisher 00-053-018-000
FDA UDI
Class IActive
614L Centrifuge, Spectra 00-008-035-000
FDA UDI
Class IActive
SERO 12, Drucker 00-483-009-000
FDA UDI
Class IActive
Boost 2+ Flex Centrifuge, SLR 00-783-232-000
FDA UDI
Class IUnknown
SERO 12 Centrifuge, Drucker, Pop Up Lid 00-483-009-001
FDA UDI
Class IActive
642M Centrifuge, LabCorp 00-077-026-000
FDA UDI
Class IActive
QBC Diagnostics 424304
FDA UDI
Class IIActive
642E Centrifuge, Orion 00-018-251-000
FDA UDI
Class IActive
642E Centrifuge, Medline 00-018-215-000
FDA UDI
Class IActive
642E Centrifuge, Labcare Plus 00-018-189-000
FDA UDI
Class IActive
642E Centrifuge, CompuNet 00-018-284-000
FDA UDI
Class IActive
642VFD Plus Centrifuge, Prizmah 00-027-097-000
FDA UDI
Class IActive
Horizon 24 Flex Centrifuge, MarketLab 00-384-148-000
FDA UDI
Class IActive
642M Centrifuge, MarketLab 00-077-148-000
FDA UDI
Class IActive
FisherBrand Model 12 Centrifuge, DASH Apex 12 00-083-018-000
FDA UDI
Class IActive
Horizon 12 Flex Centrifuge, Drucker, Brazil 00-383-009-001
FDA UDI
Class IActive
614B Centrifuge, Medline 00-004-215-000
FDA UDI
Class IActive

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