Tri-Valent™ Swab TVS-01

GUDID 10634853001388

Tri-Valent Positive Control Swab

MICROBIOLOGICS INC.

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

• Primary Device ID: 10634853001388
• NIH Device Record Key: 456e6634-8d1b-4c9e-a11c-5b48e4816ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Valent™ Swab
• Version Model Number: TVS-01
• Catalog Number: TVS-01
• Company DUNS: 060467826
• Company Name: MICROBIOLOGICS INC.
• 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(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10634853001388 [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: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [Tri-Valent™ Swab]

• 10634853001418: Vaginitis Validation Panel
• 10634853001401: Trichomonas Verification Set
• 10634853001395: Tri-Valent Negative Control Swab
• 10634853001388: Tri-Valent Positive Control Swab
• 10634853001364: Vaginitis Calibration Panel