PrepIT L2P PT-L2P-5

GUDID 00627595000415

DNA Preparation Kit, 5 ml

DNA Genotek Inc

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00627595000415
• NIH Device Record Key: b185995c-6897-4ab1-adac-c5f4dd7f325f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrepIT L2P
• Version Model Number: PT-L2P-5
• Catalog Number: PT-L2P-5
• Company DUNS: 207983508
• Company Name: DNA Genotek Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595000415 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [PrepIT L2P]

• 00627595000422: DNA Preparation Kit, 45 ml
• 00627595000415: DNA Preparation Kit, 5 ml