FDA UDI In Commercial Distribution 🇺🇸 United States

Ion Torrent

DI: 10190302000888 · Model: A30320 · LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Ion Torrent
Primary DI
10190302000888
Version / Model
A30320
Company Name
LIFE TECHNOLOGIES CORPORATION
Labeler DUNS
080131636
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-28
Public Version
2
Public Version Date
2020-11-16
Public Version Status
Update
Public Device Record Key
539d5bc3-cb4e-4959-9541-b1c8fb482fee

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

GMDN Terms

Code Name
61304 PCR/NAT negative control IVD

Identifiers

Type ID
Primary 10190302000888

Premarket Submissions

Submission Number Supplement Number
P160045 000