NATtrol™ MDZ056

GUDID 01220000260177

NATtrol™ Enterovirus (EV) Negative Control (MDZ056) is an in vitro diagnostic external run control intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ EV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. NATtrol™ EV Negative Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each NATtrol™ EV Negative Control contains 6 x 0.5 mL vials of NATtrol™ Parechovirus formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.

ZEPTOMETRIX CORPORATION

Enterovirus nucleic acid (serotypes 68-71) IVD, control

• Primary Device ID: 01220000260177
• NIH Device Record Key: 5354503d-36fd-477e-a6ce-56cd57bb3f79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATtrol™
• Version Model Number: NATtrol™ Enterovirus Negative Control
• Catalog Number: MDZ056
• Company DUNS: 184020902
• 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: false
• 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: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.com
• Phone: 1-800-274-5487
• Email: custserv@zeptometrix.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
• 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	01220000260177 [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: 2020-10-26
• Device Publish Date: 2020-10-16

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