Device
UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)
Manufacturer
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Model: D30863
Catalog: D30863
DI: 15099590807696
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1ce0d9d1-dd19-4a2a-8446-5351149814e7
Distribution Status:
In Commercial Distribution
DUNS Number:
008254708
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
15099590807696
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35476
Name: Haematological cell analyser IVD
Definition:
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.
FDA Product Codes
GKZ
Counter, Differential Cell
Premarket Submissions
Submission Number:
K240252
Supplement Number:
000