Model: 850-00001-00
DI: 00860008385871
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
dd1d0e7c-9d58-4454-98b2-938f4fb232d3
Distribution Status:
In Commercial Distribution
DUNS Number:
080636378
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:
00860008385871
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:
K243348
Supplement Number:
000