Model: 04P5530
Catalog: 04P5530
DI: 00380740225186
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
ARCHITECT i System e-Assay CD-ROM-US Version 30.0
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1c9e82cc-a5eb-4f46-9067-0d4c426d5792
Distribution Status:
In Commercial Distribution
DUNS Number:
079226220
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00380740225186
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43472
Name: Laboratory instrument/analyser application software IVD
Definition:
An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
FDA Product Codes
JJE
Analyzer, chemistry (photometric, discrete), for clinical use