Model: 850-00002-00
DI: 00860008385888
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
89c561bb-a21c-48b1-a202-cae2def5e5fe
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:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
box
Item #1 - Device ID:
10860008385885
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00860008385888
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860008385888
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
box
Item #3 - Device ID:
20860008385882
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00860008385888
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 61032
Name: Laboratory analyser cuvette IVD, single-use
Definition:
A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.
FDA Product Codes
GKZ
Counter, Differential Cell