SureFISH 12q14.1 CDK4 308kb P20RDX5

Basic Information

• Brand Name: SureFISH 12q14.1 CDK4 308kb P20RDX5
• Primary DI: 05700574025588
• Version / Model: G210978R
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-13
• Public Version: 1
• Public Version Date: 2022-05-23
• Public Version Status: New
• Public Device Record Key: cf6a3822-1a8d-481d-8d26-60823f6244d7

Device Description

SureFISH 12q14.1 CDK4 308kb P20RDX5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
MVU	Reagents, specific, analyte	Pathology	864.4020	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	05700574025588	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 Tubes (20 µl)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius