NATtrol™ NATV-BU2

GUDID 01220000260429

NATtrol™ Vaginal Mini Bundle is a packaging configuration that contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) and NATtrol Vaginal Negative Control (NATVNEG-6C), 1 each, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.

ZEPTOMETRIX CORPORATION

Multiple-type vaginitis-associated organism nucleic acid IVD, control

• Primary Device ID: 01220000260429
• NIH Device Record Key: 5edaa007-96e4-44a2-adc9-17e39e15c399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATtrol™
• Version Model Number: NATtrol™ Vaginal Mini Bundle
• Catalog Number: NATV-BU2
• 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	01220000260429 [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: 2023-12-25
• Device Publish Date: 2023-12-15

On-Brand Devices [NATtrol™]

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• 01220000260061: NATtrol™ Clostridium difficile Negative Control (MDZ041) is an in vitro, diagnostic external r
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• 01220000260047: NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Controls (MDZ004) consis
• 01220000260030: NATtrol™ Neisseria gonorrhoeae (NG) Positive Controls (MDZ003) consist of in vitro diagnostic
• 01220000260023: NATtrol™ Chlamydia trachomatis (CT) Positive Controls (MDZ002) are in vitro diagnostic externa
• 01220000260214: NATtrol™ Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) Negative
• 01220000260207: NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control (MDZ059) is an in
• 01220000260177: NATtrol™ Enterovirus (EV) Negative Control (MDZ056) is an in vitro diagnostic external run con
• 01220000260160: NATtrol™ Enterovirus (EV) Positive Control (MDZ055) is an in vitro diagnostic external run con
• 01220000260153: NATtrol™ GBS (Group B Streptococci) Negative Control (MDZ054) is an in vitro diagnostic extern
• 01220000260146: NATtrol™ GBS (Group B Streptococci) Positive Control (MDZ053) is an in vitro diagnostic extern
• 01220000260139: NATtrol™ Norovirus Negative Control (MDZ052) is an in vitro diagnostic external run control in
• 01220000260122: NATtrol™ Norovirus GII Positive Control (MDZ051) is an in vitro diagnostic external run contro
• 01220000260115: NATtrol™ Norovirus GI Positive Control (MDZ050) is an in vitro diagnostic external run control
• 01220000260108: NATtrol™ Norovirus GI/GII Positive Control (MDZ049) is an in vitro diagnostic external run con
• 01220000260092: NATtrol™ RSV Positive Control (MDZ047) is an in vitro diagnostic external run control, intende
• 01220000260085: NATtrol™ Influenza A/B Positive Control (MDZ046) is an in vitro diagnostic external run contro
• 01220000260283: NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used wit
• 01220000260276: NATNG-6MC is a qualitative in vitro diagnostic external run control intended to be used with mol
• 01220000260269: NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used wit
• 01220000260313: NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Pos
• 01220000260306: NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnostic control in
• 01220000260290: NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnostic control in
• 01220000260252: NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality
• 01220000260245: NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control m
• 01220000260238: NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control m
• 01220000260221: The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitro diagnostic e
• 12200002600184: The NATtrol™ Trichomonas vaginalis (T. vaginalis) Positive Control is an unassayed in vitro di
• 01220000260191: The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassayed in vitro di
• 01220000260184: The NATtrol™ Trichomonas vaginalis (T. vaginalis) Positive Control is an unassayed in vitro di
• 01220000260375: The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic e
• 01220000260368: The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic e
• 01220000260351: The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic e
• 01220000260344: The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic e
• 01220000260337: The NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control is an unassayed in vitro diagnostic external
• 01220000260320: The NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control is an unassayed in vitro diagnostic external
• 01220000260399: NATtrol™ CT/NG/TV Negative Control is a qualitative external run control intended to be used
• 01220000260382: NATtrol™ CT/NG/TV Positive Control is a qualitative external run control intended to be used
• 01220000260412: NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic
• 01220000260405: NATtrol™ Mpox Virus Positive Control (NATMPXVPOS-6C-IVD) is a qualitative in vitro diagnostic
• 01220000260429: NATtrol™ Vaginal Mini Bundle is a packaging configuration that contains qualitative in vitro d
• 01220000260511: NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs (NATFRCNEG-SW-IVD) is a qualitative in vit
• 01220000260504: NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control Swab (NATFRC-SW-IVD) is a qualitative in vitro di
• 01220000260535: NATtrol™ HCV Virus Negative Control (NATHCVNEG-6C-IVD) is a qualitative in vitro diagnostic ex
• 01220000260528: NATtrol™ HCV Virus Positive Control (NATHCV-6C-IVD) is a qualitative in vitro diagnostic exter