INVADER

Basic Information

• Brand Name: INVADER
• Primary DI: 15420045506558
• Version / Model: INVADER FACTOR II, 144 TESTS
• Catalog Number: 95-452
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 4
• Public Version Date: 2024-05-21
• Public Version Status: Update
• Public Device Record Key: 3a7b48de-d7d7-4d64-b438-0a3490938b25
• Distribution End Date: 2021-07-31

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPQ	TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR	Hematology	864.7280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58952	Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506558	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]