ACCUPROBE

Basic Information

• Brand Name: ACCUPROBE
• Primary DI: 15420045506190
• Version / Model: ACCUPROBE, B. DERMATITIDIS
• Catalog Number: 102890
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3a9b97a8-9d6e-4172-84c3-37435fc2ff1a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
MDC	DNA-PROBE - BLASTOMYCES DERMATITIDIS	Microbiology	866.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52018	Blastomyces dermatitidis exoantigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of exoantigens from the fungus Blastomyces dermatitidis in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506190	GS1

Premarket Submissions

Submission Number	Supplement Number
K903201	000