Model: 010101003501
Catalog: 010101003501
DI: 06947145541781
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3393022a-9eb9-46c2-81c0-3d573c0e3f8c
Distribution Status:
In Commercial Distribution
DUNS Number:
421745241
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
06947145541781
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56701
Name: Chemiluminescent immunoassay analyser IVD
Definition:
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.
FDA Product Codes
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Premarket Submissions
Submission Number:
K232587
Supplement Number:
000