AccessGUDID - DEVICE: Accelerate PhenoTest BC ID QC test (10862011000335)

GUDID

Device Identifier (DI) Information

Brand Name: Accelerate PhenoTest BC ID QC test
Version or Model: 10105158
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCELERATE DIAGNOSTICS, INC.

Primary DI Number: 10862011000335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 186328670 *Terms of Use

Device Description: The Accelerate PhenoTest™ BC ID QC test is intended to serve as an external quality control to monitor the accuracy of the organism identification calls made by the Accelerate PhenoTest™ BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest™ BC AST QC test and Accelerate PhenoTest™ BC kit.

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?
61314	Multiple-type bloodstream pathogen nucleic acid 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 nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PRH	Positive Blood Culture Identification And Ast Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160032	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: 17da9547-4984-48a5-9597-212f6a7b43b2
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: February 01, 2018