FDA UDI In Commercial Distribution 🇺🇸 United States

3500xL Dx Genetic Analyzer

DI: 10190302005944 · Model: 4405183 · LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3500xL Dx Genetic Analyzer
Primary DI
10190302005944
Version / Model
4405183
Company Name
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Labeler DUNS
628548377
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-04-24
Public Version
1
Public Version Date
2020-05-04
Public Version Status
New
Public Device Record Key
10b6a783-9c3a-4b23-a138-c944bcce3907

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PCA DNA genetic analyzer

GMDN Terms

Code Name
62070 Nucleic acid sequence analyser IVD, Sanger sequencing

Identifiers

Type ID
Primary 10190302005944