AccessGUDID - DEVICE: BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit (00382902560418)

GUDID

Device Identifier (DI) Information

Brand Name: BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit
Version or Model: 256041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 256041
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902560418
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Kit Flu A+B 30 Test Hospital Veritor

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?
49119	Influenza A/B 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 influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. 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 [?]
K120049	000
K121797	000
K132256	000
K132693	000
K133138	000
K151301	000
K152874	000
K160164	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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 394f0e76-574e-4a22-80e1-4c019a6d09ab
Public Version Date: May 15, 2025
Public Version Number: 5
DI Record Publish Date: February 02, 2017