AccessGUDID - DEVICE: API® 20 E Reagent QC (03573026588410)

GUDID

Device Identifier (DI) Information

Brand Name: API® 20 E Reagent QC
Version or Model: API® 20 E Reagent QC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026588410
Issuing Agency: GS1
Commercial Distribution End Date: October 05, 2021
Device Count: 30
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: API 20 E Reagent QC test kit is a abbreviated version of API 20 E strip containing substrates for tryptophane deaminase, indole, nitrate reduction and Voges-Proskauer tests

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?
50417	Multiple gram negative bacteria species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSS	KIT, IDENTIFICATION, ENTEROBACTERIACEAE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f0a63600-6178-4bed-b1ae-f97199123756
Public Version Date: October 28, 2021
Public Version Number: 2
DI Record Publish Date: April 10, 2020