TransPRO TPV50

GUDID 00816576025800

TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.

HARDY DIAGNOSTICS

Microbiological transport medium IVD

• Primary Device ID: 00816576025800
• NIH Device Record Key: 05383e32-a08e-4505-b540-b900a303fa26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransPRO
• Version Model Number: TPV50
• Catalog Number: TPV50
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com
• Phone: 800-266-2222
• Email: technicalservices@hardydiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576025800 [Unit of Use]
GS1	00816576026067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233534

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2024-10-16
• Device Publish Date: 2024-10-08

Devices Manufactured by HARDY DIAGNOSTICS

• 00816576025800 - TransPRO: 2024-10-16TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
• 00816576025800 - TransPRO: 2024-10-16 TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-ti
• 00816576026951 - N/A: 2024-07-16 G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other micro
• 00816576026586 - N/A: 2024-04-05 Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective an
• 00816576026876 - N/A: 2024-03-18 C. auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichme
• 00819398021593 - N/A: 2024-01-23 BHI Broth, 4mL, 100 tubes/pack (Brain Heart Infusion Broth) For the cultivation of fastidious and nonfastidious microorganisms.
• 00819398020602 - N/A: 2024-01-09 Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and sele
• 00816576026838 - HardyCHROM™: 2023-12-18 HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogen
• 00816576024391 - AnaeroGRO: 2023-12-06 Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selectiv