Device
General purpose laboratory centrifuge for sample separation.
Manufacturer
DRUCKER DIAGNOSTICS
Model: 00-289-303-000 Catalog: 00-289-303-000 DI: 00810052865003 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
General purpose laboratory centrifuge for sample separation.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 7164774c-45f9-49c3-b9c6-9e91fc2a83bc
Distribution Status: In Commercial Distribution
DUNS Number: 022156957
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810052865003
Type: Primary
Issuing Agency: GS1
GMDN
Code: 36465
Name: General-purpose centrifuge IVD
Definition:
An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.
FDA Product Codes
JQC
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use