ACCUPROBE 102910

GUDID 15420045506213

Hologic, Inc.

Multiple fungi/yeast species nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045506213
• NIH Device Record Key: cbb3a639-bdc2-4dfa-8996-fb5bc32731fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUPROBE
• Version Model Number: ACCUPROBE, H. CAPSULATUM
• Catalog Number: 102910
• 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
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896859

FDA Product Code

• MBT: DNA-PROBE, REAGENT, HISTOPLASMA CAPSULATUM

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: 2016-04-15

On-Brand Devices [ACCUPROBE]

• 15420045506459: DETECTION REAGENT KIT
• 15420045506220: ACCUPROBE, L. MONOCYTOGENES
• 15420045506213: ACCUPROBE, H. CAPSULATUM
• 15420045506206: ACCUPROBE, C. IMMITIS
• 15420045506190: ACCUPROBE, B. DERMATITIDIS
• 15420045506183: ACCUPROBE, S. AUREUS
• 15420045506176: ACCUPROBE, S. PNEUMONIAE
• 15420045506169: ACCUPROBE, M. TUBERCULOSIS
• 15420045506152: ACCUPROBE, M. KANSASII
• 15420045506145: ACCUPROBE, M. GORDONAE
• 15420045506138: ACCUPROBE, M. AVIUM COMPLEX
• 15420045506121: ACCUPROBE, M. INTRACELLULARE
• 15420045506114: ACCUPROBE, M. AVIUM
• 15420045506107: ACCUPROBE, N. GONORRHOEAE
• 15420045506091: ACCUPROBE REAGENTS, 200 TESTS