AccessGUDID - DEVICE: CellSearch (10888385000023)

GUDID

Device Identifier (DI) Information

Brand Name: CellSearch
Version or Model: 7900003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7900003
Company Name: MENARINI SILICON BIOSYSTEMS, INC.

Primary DI Number: 10888385000023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 057722858 *Terms of Use

Device Description: Circulating Tumor Cell Control Cell Kit

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:	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?
56919	Multiple CD cell marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRS	CONTROL MATERIAL, BLOOD CIRCULATING EPITHELIAL CANCER 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
Special Storage Condition, Specify: Protect reagents from exposure to bright sunlight
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: 72130eb1-fb81-4f63-ac10-8bbc087b114c
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: September 22, 2016