AccessGUDID - DEVICE: Access AccuTnI+3 Calibrators (15099590209360)

GUDID

Device Identifier (DI) Information

Brand Name: Access AccuTnI+3 Calibrators
Version or Model: A98265
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A98265
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590209360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.

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):	Yes
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?
60780	Troponin I IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

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: 94b27178-5714-4076-9992-c05de1623fd6
Public Version Date: April 09, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016