Control Set for the BD ProbeTec™ Herpes Simplex Viruses 441748

GUDID 00382904417482

Control Set for the BD ProbeTec™ Herpes Simplex Viruses (HSV1&2) Qx Amplified DNA Assays

BECTON, DICKINSON AND COMPANY

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

• Primary Device ID: 00382904417482
• NIH Device Record Key: de8bb787-93d0-4b0b-bf99-1f7a4b838330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Set for the BD ProbeTec™ Herpes Simplex Viruses
• Version Model Number: 441748
• Catalog Number: 441748
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• 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: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904417482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103798

FDA Product Code

• OQO: Herpes simplex virus nucleic acid amplification assay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-07

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382904449575 - BDXpert™ System: 2025-03-28 BDXpert™ System
• 00382904490829 - NMIC-312: 2025-03-28 NMIC-312
• 00382904490836 - NMIC/ID-313: 2025-03-28 NMIC/ID-313
• 00382906666482 - N/A: 2025-03-27 BD® CD26 (M-A261) APC
• 50382903041423 - N/A: 2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
• 30382903884378 - BD Insyte Vialon-E 20GA: 2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
• 00382902411154 - BD Francisella tularensis Antigen: 2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
• 00382902411161 - BD Francisella tularensis Antisera: 2025-03-11 Vial F Tularensis Antiserum