DML 3000 5000-00031

GUDID 04053228010777

QIAGEN SCIENCES INC.

Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated

• Primary Device ID: 04053228010777
• NIH Device Record Key: a000f98a-0870-4c17-8dd1-5377352d3db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DML 3000
• Version Model Number: 1
• Catalog Number: 5000-00031
• Company DUNS: 008675485
• Company Name: QIAGEN SCIENCES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228010777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890064

FDA Product Code

• MAQ: Kit, Dna Detection, Human Papillomavirus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-21

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