Model: SCR1-51000
DI: 06972077026785
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e7d3c5e4-9c9a-4002-a38f-a0b3f73fea0c
Distribution Status:
In Commercial Distribution
DUNS Number:
530563253
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972077026785
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60993
Name: Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen, using an enzyme immunoassay (EIA) method.
FDA Product Codes
KNN
Components, Wheelchair