Panther System 902615

GUDID 15420045504141

Hologic, Inc.

Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 15420045504141
• NIH Device Record Key: 17239999-8d87-4ba9-923e-6481083ef84c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther System
• Version Model Number: 9120900000
• Catalog Number: 902615
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111409

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-03

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