Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Basic Information

• Brand Name: Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
• Primary DI: 05700573004591
• Version / Model: GE020
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-19
• Public Version: 1
• Public Version Date: 2021-10-27
• Public Version Status: New
• Public Device Record Key: cf67f102-7090-4bc1-8352-8bb8791f5843

Device Description

Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
QQT	Immunohistochemistry assay, antibody, Ki-67	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
57337	Ki67 antigen IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Ki67 antigen in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700573004591	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P210026	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			60 Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius