AccessGUDID - DEVICE: TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT (00083059070316)

GUDID

Device Identifier (DI) Information

Brand Name: TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT
Version or Model: 7031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERICA, INC.

Primary DI Number: 00083059070316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067647321 *Terms of Use

Device Description: The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

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:	No
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?
53996	Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin T and/or troponin I in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	Immunoassay Method, Troponin Subunit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013062	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa89896f-4b49-4c58-a953-a54d9eba4818
Public Version Date: July 09, 2020
Public Version Number: 1
DI Record Publish Date: July 01, 2020