AccessGUDID - DEVICE: Cardiac Marker Control (00856743007017)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiac Marker Control
Version or Model: 150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150
Company Name: MORE DIAGNOSTICS INC

Primary DI Number: 00856743007017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829978451 *Terms of Use

Device Description: MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).

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):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
47016	Multiple cardiac marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The 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
JJT	Enzyme Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972976	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: less than -26 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6956f743-e3b8-4128-a39f-e4a79e360bc3
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 30, 2018