NATtrol™

Basic Information

• Brand Name: NATtrol™
• Primary DI: 01220000260238
• Version / Model: NATtrol™ BV Positive Control
• Catalog Number: NATBVPOS-BD
• Company Name: ZEPTOMETRIX CORPORATION
• Labeler DUNS: 081586435
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-31
• Public Version: 2
• Public Version Date: 2023-02-13
• Public Version Status: Update
• Public Device Record Key: 7dedb1cb-6e6e-4540-9bef-175aaf995c6b
• Distribution End Date: 2023-02-10

Device Description

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

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: No
• 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
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	866.3920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48210	Multiple-type vaginitis-associated organism 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 organisms associated with vaginitis in a clinical specimen. Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01220000260238	GS1

Customer Contacts

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

Storage Conditions

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