Dako

Basic Information

• Brand Name: Dako
• Primary DI: 05700571107713
• Version / Model: GC206
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-07
• Public Version: 2
• Public Version Date: 2025-09-11
• Public Version Status: Update
• Public Device Record Key: f032adc9-2faf-48a7-85a1-52fe4eadeab7

Device Description

Dako Omnis Vial with Mixing Ball, 2 mL

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
KPA	Slide stainer, automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66103	Assay stirring set IVD	A collection of containers (e.g., test tubes, cuvettes) and magnetic or non-magnetic stirring instruments (e.g., bars, balls) intended to be used to hold and facilitate the stirring/mixing of biological specimens, reagents, buffers, or other materials during in vitro diagnostic testing procedures (e.g., platelet aggregation study, clotting time assay) performed in the laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05700571112342	GS1	Box	25	In Commercial Distribution
Primary	05700571107713	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	2	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius