AccessGUDID - DEVICE: Fluoro-CheckTM Influenza A+B (00895160002526)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro-CheckTM Influenza A+B
Version or Model: TF8147
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF8147
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.

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?
49117	Influenza A/B virus antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method.	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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f4d5839-a734-4d4c-bb8b-d9c83ea821a2
Public Version Date: June 29, 2023
Public Version Number: 2
DI Record Publish Date: May 24, 2019