Control Set for the BD ProbeTec™ (CT/GC) 441125

GUDID 00382904411251

Control Set for the BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays

BECTON, DICKINSON AND COMPANY

Chlamydia trachomatis nucleic acid IVD, control Chlamydia trachomatis nucleic acid IVD, control

• Primary Device ID: 00382904411251
• NIH Device Record Key: 210dd65a-5fae-40b8-8fbf-d52b70fb33d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Set for the BD ProbeTec™ (CT/GC)
• Version Model Number: 441125
• Catalog Number: 441125
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904411251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081825

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

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: 2016-07-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 17501073025537 - Plastipak: 2024-06-25 SYRINGE 5ML LL SYRINGE ONLY MX BUN
• 30382903033806 - BD Vacutainer® Specimen Collection with BD™ Blunt Plastic Cannula: 2024-06-24 BD Vacutainer® Specimen Collection Assembly with BD™ Blunt Plastic Cannula
• 00382905168000 - BD Intelliport System: 2024-06-17 SYRINGE LABELER
• 50382905168012 - BD Intelliport System: 2024-06-17 SYRINGE LABELER LUER LABEL CASSETTE
• 60382905168026 - BD Intelliport System: 2024-06-17 SYRINGE LABELER BARREL LABEL ROLL
• 60382905168033 - BD Intelliport System: 2024-06-17 SYRINGE LABELER INK CARTRIDGE
• 00382903666188 - BD MiniDraw™ Cap Removal Tool: 2024-06-14 BD MiniDraw™ Cap Removal Tool
• 50382903677776 - BD Vacutainer® Trace Element K2 EDTA (K2E) 5.4 mg Blood Collection Tubes: 2024-06-14 TUBE TRCE PLH 13X75 3.0 PLBL R/BL EDTA