BD MAX™ TNA MMK

Basic Information

• Brand Name: BD MAX™ TNA MMK
• Primary DI: 00382904428457
• Version / Model: 442845
• Catalog Number: 442845
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-20
• Public Version: 1
• Public Version Date: 2024-02-28
• Public Version Status: New
• Public Device Record Key: fc2d1d3c-960c-4708-b76a-9f42a83db5b1

Device Description

Kit BD MAX TNA MMK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62623	Nucleic acid amplification mastermix reagent IVD	A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904428457	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius