AccessGUDID - DEVICE: Henry Schein (00304040019771)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1126219
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1126219
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040019771
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens

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):	No
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
GNX	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e450dca-df9d-49f7-97ea-1410b9d9c414
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016