Device
VALIDATE High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Manufacturer
Lgc Clinical Diagnostics, Inc.
Lgc Clinical Diagnostics, Inc.
Model: 405re
Catalog: 405re
DI: 00850011135860
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
VALIDATE High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fbf38d60-9c31-40da-9247-e424ec778439
Distribution Status:
In Commercial Distribution
DUNS Number:
075886031
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:
00850011135860
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 54000
Name: Troponin T/Troponin I IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of troponin T and/or troponin I in a clinical specimen.
FDA Product Codes
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-25
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
-10
Storage Handling - Storage Handling Type:
Storage Environment Temperature