AccessGUDID - DEVICE: Oncomine™ Dx Target Test User Guides and Assay Definition File (10190302017756)

GUDID

Device Identifier (DI) Information

Brand Name: Oncomine™ Dx Target Test User Guides and Assay Definition File
Version or Model: A51694
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302017756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080131636 *Terms of Use

Device Description: ODXTT UG & ADF V10.0 USB - USA

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61777	Human genomic analysis interpretive software	An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQP	Next generation sequencing oncology panel, somatic or germline variant detection system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160045	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4eeeae86-e1de-4a5c-9876-35576867e8dc
Public Version Date: June 04, 2024
Public Version Number: 2
DI Record Publish Date: January 23, 2022