AccessGUDID - DEVICE: CELL-DYN (00380740119836)

GUDID

Device Identifier (DI) Information

Brand Name: CELL-DYN
Version or Model: 09H72-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09H7202
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740119836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: CELL-DYN 22 Plus Control

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Full blood count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

GMDN Preferred Term Name

GMDN Definition

Full blood count IVD, control

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

FDA Product Code

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Product Code	Product Code Name
GLQ	MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111211	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 10 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd9ba7ed-5f30-4731-8dd5-584ec27c40a6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016