DML 3000

Basic Information

• Brand Name: DML 3000
• Primary DI: 04053228010777
• Version / Model: 1
• Catalog Number: 5000-00031
• Company Name: QIAGEN SCIENCES INC.
• Labeler DUNS: 008675485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-21
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: a000f98a-0870-4c17-8dd1-5377352d3db5

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
36910	Photometer, absorbance/transmission, automated	An electrically-powered, automated, stand-alone laboratory instrument intended to be used to determine the absorbance or transmission of light energy transmitted through a substance, typically a solution/liquid (e.g., saliva, urine), or gas. It is used for diagnostic and/or research purposes and detects scattered light intensity, absorption and/or fluorescence.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228010777	GS1

Premarket Submissions

Submission Number	Supplement Number
P890064	000