ACCUPROBE®

Basic Information

• Brand Name: ACCUPROBE®
• Primary DI: 15420045506459
• Version / Model: KIT DETECTION RGT (CE)
• Catalog Number: 201791
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-02
• Public Version: 3
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 5d08a4ba-65d5-4fe0-9515-eaa9dc2a55c7

Device Description

Detection Reagent Kit.

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
51178	Mycobacterium tuberculosis 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 the bacteria Mycobacterium tuberculosis in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506459	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius