AccessGUDID - DEVICE: Alere Triage® (00899722002740)

GUDID

Device Identifier (DI) Information

Brand Name: Alere Triage®
Version or Model: 97300EU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 97300EU
Company Name: ALERE SAN DIEGO, INC.

Primary DI Number: 00899722002740
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 194854949 *Terms of Use

Device Description: Alere Triage® Profiler SOB™ Panel

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:	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
NBC	Test,Natriuretic Peptide
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
DDR	Myoglobin, Antigen, Antiserum, Control
MMI	Immunoassay Method, Troponin Subunit
JHX	Fluorometric Method, Cpk Or 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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d607427f-3393-4686-ae6b-d07abbbabbd6
Public Version Date: August 23, 2023
Public Version Number: 3
DI Record Publish Date: September 26, 2016