Device
Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480 is used for the quantitative determination of creatinine concentration in serum or urine on TC Matrix analyzers
Manufacturer
TECO DIAGNOSTICS
TECO DIAGNOSTICS
Model: C514-650TC4
Catalog: C514-650TC4
DI: 10673486014044
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480 is used for the quantitative determination of creatinine concentration in serum or urine on TC Matrix analyzers
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
69a9e787-d680-4ded-ad00-5865ec872509
Distribution Status:
In Commercial Distribution
DUNS Number:
185067774
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:
10673486014044
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 53252
Name: Creatinine IVD, reagent
Definition:
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.
FDA Product Codes
CGX
Alkaline Picrate, Colorimetry, Creatinine
Premarket Submissions
Submission Number:
K880629
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature