AccessGUDID - DEVICE: Fluoro-CheckTM beta-hCG (00895160002519)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro-CheckTM beta-hCG
Version or Model: TF8146
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF8146
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002519
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 determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma.

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?
58789	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JHI	Visual, Pregnancy Hcg, Prescription Use

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: c952e5ca-5d8f-4a8d-85b1-0c79476662f6
Public Version Date: June 29, 2023
Public Version Number: 4
DI Record Publish Date: April 25, 2018