AccessGUDID - DEVICE: Oncomine™ DX Target DNA Control v2.0 (10190302015134)

GUDID

Device Identifier (DI) Information

Brand Name: Oncomine™ DX Target DNA Control v2.0
Version or Model: A44913
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302015134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080131636 *Terms of Use

Device Description: No description.

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?
41906	Nucleic acid hybridization detection IVD, control	A material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].	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: 739e3b34-151a-4715-97b6-0814d8597e2f
Public Version Date: January 22, 2021
Public Version Number: 1
DI Record Publish Date: January 14, 2021