BD PCR Cartridge

Basic Information

• Brand Name: BD PCR Cartridge
• Primary DI: 30382904375196
• Version / Model: 437519
• Catalog Number: 437519
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2017-04-04
• Public Version: 7
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 1b81db97-f822-4807-94a7-56e5fc36ff46

Device Description

BD PCR Cartridges 24EA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2
NJR	Nucleic acid amplification assay system, group b streptococcus, direct specimen test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904375196	GS1
Unit of Use	00382904375195	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111860	000

Storage Conditions

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