AccessGUDID - DEVICE: Nano-CheckTM AMI 3 in 1 (00895160002090)

GUDID

Device Identifier (DI) Information

Brand Name: Nano-CheckTM AMI 3 in 1
Version or Model: CD301S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD301S
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002090
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 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?
47399	Multiple cardiac marker IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. These cardiac markers 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
JHT	Chromatographic Separation, Cpk Isoenzymes
DDR	Myoglobin, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050975	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: 394b6b4e-f109-4b6d-ae00-a3c0ea0bea6d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016