Model: B01103102
Catalog: B01103102
DI: 00192721001494
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
PGDx elio™ plasma focus Dx software
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fc8bcd1e-808b-4e0e-a5de-fb9ed64a2804
Distribution Status:
In Commercial Distribution
DUNS Number:
963427120
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00192721001494
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60943
Name: Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Definition:
A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).
FDA Product Codes
SBY
High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Premarket Submissions
Submission Number:
DEN230046
Supplement Number:
000