NATtrol™

Basic Information

• Brand Name: NATtrol™
• Primary DI: 01220000260498
• Version / Model: NATtrol™ Meningitis/Encephalitis (ME) Controls
• Catalog Number: NATMEC-BIO-IVD
• Company Name: ZEPTOMETRIX CORPORATION
• Labeler DUNS: 081586435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-23
• Public Version: 1
• Public Version Date: 2025-07-31
• Public Version Status: New
• Public Device Record Key: e0a9396d-2595-4729-ab21-416196ea99a1

Device Description

NATtrol™ Meningitis/Encephalitis (ME) Controls (NATMEC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Cytomegalovirus, E. coli, Echovirus Type 11, HHV-6B, S. pneumoniae, C. gattii, HSV-1, N. meningitidis serogroup A, S. agalactiae, H. influenzae, HSV-2, L. monocytogenes serotype 1/2b, Parechovirus Type 3, VZV.

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
61045	Multiple-type meningitis-associated microorganism nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with meningitis, in a clinical specimen. Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01220000260498	GS1

Customer Contacts

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

Storage Conditions

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