NATtrol™ NATCTNGTV-NEG-IVD

GUDID 01220000260399

NATtrol™ CT/NG/TV Negative Control is a qualitative external run control intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance.

ZEPTOMETRIX CORPORATION

Multiple-type sexually transmitted pathogen nucleic acid IVD, control

• Primary Device ID: 01220000260399
• NIH Device Record Key: 9c19f17c-4ae2-4b9e-9825-cea9508bd1e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATtrol™
• Version Model Number: NATtrol™ CT/NG/TV Negative Control
• Catalog Number: NATCTNGTV-NEG-IVD
• Company DUNS: 081586435
• Company Name: ZEPTOMETRIX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 800-274-5487
• Email: zepto.customerservice@antylia.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	01220000260399 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-16
• Device Publish Date: 2023-03-08

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