VP2000 08N16-001

GUDID 00884999038189

VP 2000 Pretreatment Kit

ABBOTT MOLECULAR INC.

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 00884999038189
• NIH Device Record Key: 4308c716-e1c6-4a2c-8281-1a50d6cfd3d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VP2000
• Version Model Number: 08N16-001
• Catalog Number: 08N16-001
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR 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: true
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999038189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110012

FDA Product Code

• OWE: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2015-07-31

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• 00884999046115: VP 2000 Processor, 117V
• 00884999046108: VP 2000 Processor, 230V
• 00884999038189: VP 2000 Pretreatment Kit
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• 00884999001916: VP2000 Processor
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• 00884999001879: VP 2000 Protease Buffer (0.01 N HCl) 500 mL For Laboratory Use
• 00884999001862: VP 2000 Pretreatment Reagent 500 for Laboratory Use
• 00884999048478: VP 2000 System Software v2.1 with Protocols USB