NATtrol™

Basic Information

• Brand Name: NATtrol™
• Primary DI: 01220000260412
• Version / Model: NATtrol™ Mpox Virus Negative Control
• Catalog Number: NATMPXVNEG-6C-IVD
• Company Name: ZEPTOMETRIX CORPORATION
• Labeler DUNS: 081586435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-13
• Public Version: 1
• Public Version Date: 2023-11-21
• Public Version Status: New
• Public Device Record Key: 61045d31-e3e5-452e-8586-56f7b747e63b

Device Description

NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Mpox virus nucleic acids.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• 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
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66371	Monkeypox virus nucleic acid IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from monkeypox virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01220000260412	GS1

Customer Contacts

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

Storage Conditions

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