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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 24 Flex Centrifuge, Zoetis Universal Centrifuge 00-384-092-000
FDA UDI
Class IActive
DASH Apex 6 Centrifuge, BD Columbia 00-076-200-000
FDA UDI
Class IActive
842VES Centrifuge, Fisher, Standard 00-051-018-001
FDA UDI
Class IActive
614B Centrifuge, Mako 00-004-179-000
FDA UDI
Class IActive
SERO 12 Centrifuge, LabForce, Pop Up Lid 00-483-210-001
FDA UDI
Class IActive
Horizon 6FA Centrifuge, RegenLab 00-276-088-000
FDA UDI
Class IActive
642B Centrifuge, Antech 00-016-121-000
FDA UDI
Class IActive
Boost 2+ Max Centrifuge, Drucker 00-263-009-000
FDA UDI
Class IActive
642E Centrifuge, True Health Diagnostics 00-018-091-000
FDA UDI
Class IActive
Horizon 6 Flex FA Modified (DC) Centrifuge, Drucker, Autoclavable 00-376-009-010
FDA UDI
Class IActive
DASH Apex 6 Centrifuge, VWR 00-076-037-000
FDA UDI
Class IActive
642B Centrifuge, Drucker 00-016-009-001
FDA UDI
Class IActive
TrueBond DC Centrifuge, Drucker 00-376-009-009
FDA UDI
Class IActive
642E Centrifuge, LabForce 00-018-210-000
FDA UDI
Class IActive
853VES Centrifuge, Gamma Dynacare 00-054-098-000
FDA UDI
Class IActive
QBC Diagnostics 427414
FDA UDI
Class IIActive
Boost 2+ Flex Centrifuge, MD Biologix 00-783-254-000
FDA UDI
Class IActive
DASH Coag Centrifuge, Boekel 00-676-260-000
FDA UDI
Class IUnknown
Horizon 6 Flex FA Centrifuge, Boekel 00-376-260-001
FDA UDI
Class IActive
Boost 2+ Flex Centrifuge, Holding Technologies 00-783-228-000
FDA UDI
Class IActive
642E Centrifuge, Exam One 00-018-017-000
FDA UDI
Class IActive
DASH Apex 4 Centrifuge, VWR 00-053-037-000
FDA UDI
Class IActive
642E Centrifuge, Ascend Clinical 00-018-051-001
FDA UDI
Class IActive
Horizon 24 Flex Centrifuge, Greiner Bio-One 00-384-024-000
FDA UDI
Class IActive
Horizon 12 Centrifuge, Davita 00-283-008-000
FDA UDI
Class IActive
614B Centrifuge, Glofinn 00-004-102-000
FDA UDI
Class IActive
QBC Diagnostics 429002
FDA UDI
Class IIActive
614B Centrifuge, Labforce 00-004-210-000
FDA UDI
Class IActive
QBC Diagnostics 424345
FDA UDI
Class IIActive
642VES Centrifuge, Lavender Medical 00-024-133-000
FDA UDI
Class IActive
Horizon 6 Flex Centrifuge, CME 00-376-252-000
FDA UDI
Class IActive
642E Centrifuge, OSF Healthcare 00-018-220-000
FDA UDI
Class IActive
Horizon 6FA Centrifuge, Drucker Modified 00-276-009-004
FDA UDI
Class IActive
Horizon 6FA Centrifuge, RegenLab, Swiss 00-276-088-001
FDA UDI
Class IActive
Horizon 12 Centrifuge, Fisher 00-283-018-000
FDA UDI
Class IActive
SERO 12 Centrifuge, Boekel 00-483-260-000
FDA UDI
Class IActive
755-24 Centrifuge, Spectra East 00-040-035-000
FDA UDI
Class IActive
Horizon 6 Flex DC Centrifuge, Alvedia, TrueBond 00-376-258-000
FDA UDI
Class IActive
QBC Diagnostics 4237-300-001
FDA UDI
Class IActive
755VES Centrifuge, 230V, Drucker, 6-Place PP Rotor, 4300RPM 00-046-009-002
FDA UDI
Class IActive
642E Centrifuge, Element 00-018-195-000
FDA UDI
Class IActive
642E Centrifuge, Labcorp 00-018-026-001
FDA UDI
Class IActive
DASH Apex 12 Centrifuge, Drucker (PST / SST) 00-083-009-000
FDA UDI
Class IActive
Horizon 6 Centrifuge, MarketLab 00-276-148-000
FDA UDI
Class IActive
755V-24 Centrifuge, Quest 00-043-032-000
FDA UDI
Class IActive
Horizon 24 Flex Centrifuge, East Side Clinical 00-384-060-000
FDA UDI
Class IActive
QBC Diagnostics 253037
FDA UDI
Class IIActive
Horizon 24 Flex Centrifuge, Dr. PRP, Universal Rotor (4) 00-389-107-001
FDA UDI
Class IActive
Horizon 12 Flex Centrifuge, East Side Clinical 00-383-060-000
FDA UDI
Class IActive
755VES Centrifuge, 230V, Drucker, 4-Place PP Rotor 00-046-009-000
FDA UDI
Class IActive

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