INVADER 95-454

GUDID 15420045506671

Hologic, Inc.

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045506671
• NIH Device Record Key: 90537592-1a69-4225-8fdb-6ccde47f7a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVADER
• Version Model Number: INVADER MTHFR 677, 144 TESTS
• Catalog Number: 95-454
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100496

FDA Product Code

• OMM: Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr

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: 2016-08-29

On-Brand Devices [INVADER]

• 15420045506732: HOLOGIC DNA EXTRACTION KIT - DOMESTIC
• 15420045506725: None
• 15420045506718: INVADER MTHFR 677, 1680 TESTS
• 15420045506701: None
• 15420045506695: INVADER FACTOR II, 1680 TESTS
• 15420045506688: INVADER MTHFR 1298, 144 TESTS
• 15420045506671: INVADER MTHFR 677, 144 TESTS
• 15420045506664: None
• 15420045506558: INVADER FACTOR II, 144 TESTS