ISH Pepsin (Dako Omnis)

Basic Information

• Brand Name: ISH Pepsin (Dako Omnis)
• Primary DI: 05700572035398
• Version / Model: GM302
• Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD
• Labeler DUNS: 894671143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-17
• Public Version: 2
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 2c4c0c20-c1ff-4f9c-81b0-7b22861211c2

Device Description

ISH Pepsin (Dako Omnis)

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
NJT	IMMUNOHISTOCHEMISTRY REAGENTS AND KITS	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42703	Specimen preparation enzyme reagent IVD	An enzymatic substance or reactant intended to be used alone or in combination with other IVDs for the liquefication or digestion of clinical laboratory specimens containing mucoid or clumped material in preparation for further processing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572035398	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	7	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 8 Degrees Celsius