AccessGUDID - DEVICE: BD™ Multi-Check (00382903409143)

GUDID

Device Identifier (DI) Information

Brand Name: BD™ Multi-Check
Version or Model: 340914
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 340914
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903409143
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: BD Multi-Check™ CD4 Low Ctrl 1X2.5mL IVD

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):	No
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?
66463	CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the CD4 cell marker in a clinical specimen, using a fluorescent activated cell sorting/ flow cytometry (FACS/Flow) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

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: c9b72ba5-10ad-4a3c-9b43-7d5c10b205c0
Public Version Date: April 13, 2023
Public Version Number: 5
DI Record Publish Date: June 08, 2016