digene® HC2 CT/GC DNA Test 5130-1220

GUDID 04053228010265

QIAGEN SCIENCES INC.

Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 04053228010265
• NIH Device Record Key: f19fef6a-d909-442e-abf5-2eac83532d88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: digene® HC2 CT/GC DNA Test
• Version Model Number: 2
• Catalog Number: 5130-1220
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04053228010265 [Primary]

FDA Product Code

• LSL: Dna-Reagents, Neisseria

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-04

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