ACCUPROBE 102890

GUDID 15420045506190

Hologic, Inc.

Blastomyces dermatitidis exoantigen IVD, reagent Blastomyces dermatitidis exoantigen IVD, reagent

• Primary Device ID: 15420045506190
• NIH Device Record Key: 3a9b97a8-9d6e-4172-84c3-37435fc2ff1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUPROBE
• Version Model Number: ACCUPROBE, B. DERMATITIDIS
• Catalog Number: 102890
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903201

FDA Product Code

• MDC: DNA-PROBE - BLASTOMYCES DERMATITIDIS

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