AccessGUDID - DEVICE: Fluoro-CheckTM AMI 3 in 1 (00895160002496)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro-CheckTM AMI 3 in 1
Version or Model: TF3154
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF3154
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002496
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB 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?
47384	Multiple cardiac marker IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	Immunoassay Method, Troponin Subunit
DDR	Myoglobin, Antigen, Antiserum, Control
JHT	Chromatographic Separation, Cpk Isoenzymes

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84d4197f-0af9-4868-9802-16b03495cdd8
Public Version Date: June 03, 2019
Public Version Number: 1
DI Record Publish Date: May 24, 2019