THIRD WAVE 96-016

GUDID 15420045506633

None

Hologic, Inc.

Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

• Primary Device ID: 15420045506633
• NIH Device Record Key: 7c8502bd-a75d-475d-acaa-0e1f83d7727c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THIRD WAVE
• Version Model Number: UNIVERSAL ARM6/RED FRET
• Catalog Number: 96-016
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• 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)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506633 [Primary]

FDA Product Code

• PPM: General purpose reagent

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: 2016-09-12

On-Brand Devices [THIRD WAVE]

• 15420045506657: None
• 15420045506640: None
• 15420045506633: None
• 15420045506626: None
• 15420045506619: None
• 15420045506602: None
• 15420045506596: None
• 15420045506589: None
• 15420045506572: None
• 15420045506565: UNIVERSAL ARM1/FAM FRET