Ion Torrent™ Dx No Template Control Kit

Basic Information

• Brand Name: Ion Torrent™ Dx No Template Control Kit
• Primary DI: 10190302006156
• Version / Model: A32444
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 080131636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 6
• Public Version Date: 2020-09-29
• Public Version Status: Update
• Public Device Record Key: 125415a3-f03b-4bb4-b130-2c4d8462fea5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQP	Next generation sequencing oncology panel, somatic or germline variant detection system	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61304	PCR/NAT negative control IVD	A material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190302006156	GS1

Premarket Submissions

Submission Number	Supplement Number
P160045	000