NATtrol™ External Run Control Catalog Number: NATMGN-ERC

PRODUCT DESCRIPTION: PRECAUTIONS:

NATtrol™ Mycoplasma genitalium External Run Control  Although NATMGN-ERC contains inactivated (NATMGN-ERC)* is formulated with purified, intact bacterial bacterial cells, it should be handled as if potentially cells that have been chemically modified to render them non- infectious. infectious and refrigerator stable. Each control pack contains  Use Universal Precautions when handling this 6 x 0.25 mL vials of NATtrol™ Mycoplasma genitalium at the product. level listed in Table 1. These controls are supplied in a  To avoid cross-contamination, use separate pipette purified protein matrix that mimics the composition of a true tips for all reagents. clinical specimen. RECOMMENDED STORAGE: *Pat.:http://www.zeptometrix.com/patent-information/  NATtrol™ Mycoplasma genitalium External Run INTENDED USE: Control should be stored at 2-8°C.

 NATtrol™ Mycoplasma genitalium External Run INSTRUCTIONS FOR USE: Control is designed to evaluate the performance of tests for determination of the presence  Mix thoroughly. of Mycoplasma genitalium DNA. NATMGN-ERC can  Extract nucleic acids prior to use in downstream also be used for validation of clinical assays, assays. development of diagnostic tests and training of  Follow manufacturer instructions for integrated laboratory personnel. sample to result assays.  NATMGN-ERC contains intact bacterial cells and should be run in a manner similar to that used for TABLE 1: clinical specimens.

ETIOLOGIC STATUS/BIOHAZARD TESTING: Catalog Number Ct Range**

 NATtrol™ inactivation was carried out on the Mycoplasma genitalium stock used to formulate this NATMGN-ERC 28 - 31 product. The inactivation was verified by the absence of bacterial growth in validated growth assays. **Cycle threshold (Ct) range is based on an in-house real time PCR assay targeting the Mycoplasma genitalium  Purified protein matrix used in the manufacture of adhesin gene. this product is treated with 0.09% sodium azide. It was manufactured from materials that have been DO NOT USE IN HUMANS. FOR RESEARCH USE ONLY. tested and found non-reactive at the donor level for NOT FOR USE IN DIAGNOSTIC PROCEDURES. HIV-1/HIV-2 , HBsAg and HCV Antibody by FDA licensed donor screening test methods. All These products are intended for research, product materials are also tested for HIV-1 and HCV by FDA development, quality assurance or manufacturing use. These products are NOT intended for use in the manufacture or approved Nucleic Acid Test (NAT) methods. Heat processing of injectable products subject to licensure under inactivated bovine based source materials used in section 351 of the Public Health Service Act or for any other the manufacture of this product meet applicable product intended for administration to humans. USDA requirements for abattoir sourced animals, traceability and country of origin. The materials were collected at USDA licensed establishments or legally imported from countries recognized by the USDA as negligible or controlled for risk for Bovine Spongiform Encephalopathy (BSE) and other exotic disease agents. Donor animals were inspected ante and post mortem at the abattoir as required by the USDA.

Catalog Temperature ZeptoMetrix Corporation Number Limitation This product was manufactured in a facility 878 Main Street Expiration Lot Number which has a Quality Management System Date Buffalo, NY 14202 that is ISO 13485 certified. For Research Biological 800-274-5487 Use Only Risk www.zeptometrix.com

PINATMGN-ERC Revision: 00 PCA# N/A Effective date: 02/05/2019 Page 1 of 1