AccessGUDID - DEVICE: BD Respiratory Viral Panel for BD MAX™ System (00382904453732)

GUDID

Device Identifier (DI) Information

Brand Name: BD Respiratory Viral Panel for BD MAX™ System
Version or Model: 445373
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 445373
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904453732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Respiratory Viral Panel for BD MAX™ System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47922	Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOF	Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents
QQX	Respiratory specimen nucleic acid SARS-CoV-2 test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230956	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4a756e0-fd9a-4012-91ed-56ad9401b6cd
Public Version Date: August 28, 2024
Public Version Number: 3
DI Record Publish Date: September 28, 2023