Device
1418-0067
Manufacturer
MEDICON HELLAS S.A.
Model: 1418-0067 Catalog: 1418-0067 DI: 05204309039814 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: 5cf4a168-055d-43ac-8939-0653b31071f8
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: 05204309039814
Type: Primary
Issuing Agency: GS1
GMDN
Code: 53462
Name: Triglyceride IVD, reagent
Definition:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of triglycerides in a clinical specimen.
FDA Product Codes
None