AccessGUDID - DEVICE: BD FACSCount™ (00382903401673)

GUDID

Device Identifier (DI) Information

Brand Name: BD FACSCount™
Version or Model: 340167
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 340167
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903401673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: BD FACSCount Reagent Kit 50 Tests 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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple mature lymphocyte 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 multiple cell markers expressed on normal and/or aberrant mature lymphocytes [B lymphocytes, T lymphocytes and natural killer (NK) cells] in a clinical specimen, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.

FDA Product Code

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Product Code	Product Code Name
GKL	COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K933486	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
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: 276cb55f-51a2-4966-bd19-79270f77103f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 08, 2016