Ion PGM™ Dx Library Equalizer

Basic Information

• Brand Name: Ion PGM™ Dx Library Equalizer
• Primary DI: 10190302006163
• Version / Model: A18929
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 080131636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-14
• Public Version: 5
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: a1cd2a9a-c896-46cc-8523-ba88b32d9bce

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: Yes
• 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
PFT	Reagents for molecular diagnostic test systems	Clinical Chemistry	862.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60120	Nucleic acid hybridization detection IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190302006163	GS1