Model: 1419-0042
Catalog: 1419-0042
DI: 05204309087235
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:
30a548a6-a539-4e9c-901c-44b9344902b9
Distribution Status:
In Commercial Distribution
DUNS Number:
728553111
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05204309087235
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 53359
Name: Total cholesterol lipid IVD, kit, spectrophotometry
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.
FDA Product Codes
None