AccessGUDID - DEVICE: CD-Chex Plus (00844509000129)

GUDID

Device Identifier (DI) Information

Brand Name: CD-Chex Plus
Version or Model: 213344
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213344
Company Name: STRECK, INC.

Primary DI Number: 00844509000129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.

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 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
GGL	Control, White-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 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2.5 Milliliter

Device Record Status

Public Device Record Key: 30e0dcde-9c69-484c-acc6-77c81b008073
Public Version Date: November 20, 2023
Public Version Number: 4
DI Record Publish Date: September 16, 2016