NATtrol™ NATSARS(COV2)-ERC1-IVD

GUDID 01220000260368

The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. 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 errors. NATtrol™ SARS-Related Coronavirus 2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.

ZEPTOMETRIX CORPORATION

SARS-CoV-2 nucleic acid IVD, control

• Primary Device ID: 01220000260368
• NIH Device Record Key: 5ad9558d-a5b0-4ec2-a32f-4461016dc989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATtrol™
• Version Model Number: NATtrol™ SARS-Related Coronavirus 2 Positive Contr
• Catalog Number: NATSARS(COV2)-ERC1-IVD
• 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: 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: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• Email: zepto.customerservice@antylia.com
• Phone: 1-800-274-5487
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	01220000260368 [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: 2022-11-11
• Device Publish Date: 2022-11-03

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