ACCUPROBE®

Basic Information

• Brand Name: ACCUPROBE®
• Primary DI: 15420045506145
• Version / Model: KIT, ACCUPROBE,M. GORDONAE
• Catalog Number: 102850
• 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: 4
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 3765d2b7-99d6-4067-ae69-f12c32583529

Device Description

AccuProbe® Mycobacterium gordonae.

Device Characteristics

• Single Use: No
• 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
LQF	DNA-REAGENTS, MYCOBACTERIUM SPP.	Microbiology	866.3370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51149	Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Mycobacterium bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506145	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K896492	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius