AccessGUDID - DEVICE: MicroScan (15099590704117)

GUDID

Device Identifier (DI) Information

Brand Name: MicroScan
Version or Model: B1017-438
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590704117
Issuing Agency: GS1
Commercial Distribution End Date: December 29, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: Neg Urine Combo 88

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?
58605	General-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQM	Gram Negative Identification Panel
LTW	Susceptibility Test Cards, Antimicrobial
LTT	Panels, Test, Susceptibility, Antimicrobial
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
JWY	Manual Antimicrobial Susceptibility Test Systems

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: ebcf8de1-254a-419d-9d5b-59dea964d53a
Public Version Date: December 30, 2024
Public Version Number: 3
DI Record Publish Date: May 11, 2018