AccessGUDID - DEVICE: BD Veritor™ System CLIA-Waived Combo Pack (00382902560715)

GUDID

Device Identifier (DI) Information

Brand Name: BD Veritor™ System CLIA-Waived Combo Pack
Version or Model: 256071
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 256071
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902560715
Issuing Agency: GS1
Commercial Distribution End Date: June 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
64770	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses and/or adenoviruses. This is a rapid test 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
PSZ	Devices detecting influenza A, B, and C virus antigens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112277	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba3629a9-2217-4e6e-bd78-5706b2358a6a
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: May 25, 2018